xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032377</url>
    </required_header>
    <id_info>
      <org_study_id>BH210177</org_study_id>
      <nct_id>NCT06032377</nct_id>
    </id_info>
    <brief_title>Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints</brief_title>
    <acronym>e-COSMOS</acronym>
    <official_title>Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized controlled clinical trial is to assess a novel&#xD;
        cognitive-behavioral program for sleep and mental health using a multidomain web platform&#xD;
        (eCBTi+) in participants with insomnia and subjective memory decline. The main questions it&#xD;
        aims to answer are:&#xD;
  &#xD;
          -  Whether the eCBTi+ intervention improves sleep (subjective: Insomnia severity index&#xD;
             [ISI], objective: EEG-based sleep efficiency) sleep and mental health (Geriatric Anxiety&#xD;
             Index [GAI] and Geriatric Depression Scale [GDS]) compared to the control intervention&#xD;
  &#xD;
          -  Whether the eCBTi+ intervention improves cognitive abilities (subjective: Everyday&#xD;
             Cognition [ECog], objective: CANTAB executive functions composite score) compared to the&#xD;
             control intervention&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants with insomnia disorder will complete:&#xD;
  &#xD;
          -  A phone interview&#xD;
  &#xD;
          -  Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring&#xD;
             devices)&#xD;
  &#xD;
          -  9 nights of at-home polysomnography with an EEG headband (3 times x 3 nights)&#xD;
  &#xD;
          -  42 sleep diaries (3 times x 14 days)&#xD;
  &#xD;
          -  42 days wearing an actigraphy device (3 times x 14 days)&#xD;
  &#xD;
          -  Online questionnaires&#xD;
  &#xD;
          -  3 cognitive testing sessions&#xD;
  &#xD;
          -  10 modules of online information on health, over the course of 10 weeks&#xD;
  &#xD;
          -  In MRI subgroup: 2 in-person testing&#xD;
  &#xD;
        Good sleeper participants will complete:&#xD;
  &#xD;
          -  A phone interview&#xD;
  &#xD;
          -  Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring&#xD;
             devices)&#xD;
  &#xD;
          -  3 nights of at-home polysomnography with an EEG headband&#xD;
  &#xD;
          -  14 sleep diaries&#xD;
  &#xD;
          -  14 days wearing an actigraphy device&#xD;
  &#xD;
          -  Online questionnaires&#xD;
  &#xD;
          -  1 cognitive testing session&#xD;
  &#xD;
          -  1 in person session for MRI.&#xD;
  &#xD;
        In addition, researchers will compare outcomes from participants with insomnia and subjective&#xD;
        memory decline to a group of good sleepers to have normative values for imaging data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants with insomnia and subjective memory decline are randomized into 2 groups with a 1:1 allocation ratio, after the pre-treatment assessment. Allocation will be stratified based on a composite mental health score. An assessment post-intervention will occur 10 weeks after the start of the intervention and a follow-up assessment 24 weeks after the start of the intervention.&#xD;
  One group will receive the online CBT for sleep and mental health after the baseline assessment and the other group will receive the control intervention. The group receiving the control intervention will access the CBT intervention after completion of the study.&#xD;
  A good sleepers group, matched on age and gender, will also be recruited and assessed at baseline only to provide a normative reference group.&#xD;
  A subgroup of participants and the good sleepers group will undergo MRI and classical neuropsychological testing at baseline and 24 weeks after the start of the intervention.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Insomnia severity index</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Subjective cognitive abilities based on the everyday cognition questionnaire</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Everyday cognition Questionnaire (ECog) total score as well as number of items with a score ≥ 3. The ECog comprises 39 items and total score corresponds to the sum of all completed items, divided by the number of items completed; thus, total scores range from 1-4. Higher score means more severe cognitive impairment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective cognitive performance based on a composite score for executive functions from the CANTAB</measure>
      <time_frame>At baseline and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in the Cambridge Neuropsychological Test Automated Battery (CANTAB) executive functions composite score (Intra-Extra Dimensional Set Shift [IED] and Stocking of Cambridge [SOC], ranging from 0 to 100 with higher scores reflecting poorer executive functions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Geriatric anxiety index</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Geriatric depression scale</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep quality based on the Pittsburgh sleep quality index</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Pittsburgh sleep quality index. PSQI scores range from 0 to 21, higher scores mean worse sleep quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on actigraphy: Sleep Efficiency</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Sleep Efficiency (SE) from actigraphs. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on actigraphy: Sleep Latency</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Sleep Latency (SL) from actigraphs. Sleep latency in minutes, greater values mean longer time to fall asleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on actigraphy: Total Sleep Time</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Total Sleep Time (TST) from actigraphs. Total Sleep Time in minutes, greater values mean longer time spent asleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on actigraphy: Wake After Sleep Onset</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Wake After Sleep Onset (WASO) from actigraphs. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on EEG: Sleep Efficiency</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Sleep Efficiency (SE) from EEG. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on EEG: Sleep Latency</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Sleep Latency (SL) from EEG. Sleep latency in minutes, greater values mean longer time to fall asleep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on EEG: Total Sleep Time</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Total Sleep Time (TST) from EEG. Total Sleep Time in minutes, greater values mean longer time spent asleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on EEG: Wake After Sleep Onset</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Wake After Sleep Onset (WASO) from EEG. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on EEG: Slow Wave Activity</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Slow Wave Activity (SWA) power density from EEG.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective sleep measures based on EEG: Slow Wave Sleep</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Slow Wave Sleep (SWS) from EEG. Slow Wave Sleep in minutes, greater values mean longer time spent in Slow Wave Sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective sleep measures based on sleep diaries: Sleep Efficiency</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Sleep Efficiency (SE) from sleep diaries. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective sleep measures based on sleep diaries: Sleep Latency</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Sleep Latency (SL) from sleep diaries. Sleep latency in minutes, greater values mean longer time to fall asleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective sleep measures based on sleep diaries: Total Sleep Time</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Total Sleep Time (TST) from sleep diaries. Total Sleep Time in minutes, greater values mean longer time spent asleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective sleep measures based on sleep diaries: Wake After Sleep Onset</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Wake After Sleep Onset (WASO) from sleep diaries. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Rapid Visual Information Processing RVP - A' (sensitivity to the target sequence) and probability of false alarm (range: 0.00 - 1.00; bad to good)].</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive performances from the CANTAB: Spatial Span (SSP)</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Spatial Span [SSP - Forward/Reverse Span Lengths (range: 2-9; bad to good]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive performances from the CANTAB: Spatial Working Memory (SWM)</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Spatial Working Memory [SWM - Number of times the subject incorrectly revisits a box in which a token has previously been found (range: 0 - ∞; good to bad)].</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive performances from the CANTAB: Paired Associates Learning (PAL)</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Paired Associates Learning [PAL - Total errors adjusted (range: 0 - 70; good to bad; First attempt memory score (range: 0-20; bad to good)]</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Pattern Recognition Memory [PRM - Percent correct immediate/delayed (range: 0-100; bad to good)].</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Intra-Extra Dimensional Set Shift, IED - number of times that the subject failed to select the stimulus compatible with the current rule on the stage where the extra-dimensional shift occurs (range: 0-50; good to bad); Total errors adjusted (range: 0-402; good to bad)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Stocking of Cambridge, SOC - Number of problems successfully completed in the minimum possible number of moves (range: 0 - 12; bad to good); Mean number of moves required to complete problems (range: 5 - 12; good to bad); Initial thinking time median (range: 0 ms to ∞; longer times may indicate better planning efforts</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)</measure>
      <time_frame>At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Change in Emotional Bias Task (EBT) subscales from the CANTAB [EBT - proportion of trials rated as 'Happy' (range: 0-15, bad to good)].</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Memory encoding fMRI activations</measure>
      <time_frame>At baseline, at 24 weeks after the start of the intervention</time_frame>
      <description>Change in fMRI activation level (arbitrary units) in the hippocampus, temporal lobe and prefrontal cortex during the memory encoding task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive performance (classical neuropsychological tests)</measure>
      <time_frame>At baseline, at 24 weeks after the start of the intervention</time_frame>
      <description>all subscales from classical neuropsychological test battery (Trail Making Test A [TMT-A], Digit Symbol Substitution test (WAIS), Boston Naming Test, Digit Span - forward and backward (WAIS), Rey Auditory Verbal Learning test, Logical Memory I and II (Wechsler Memory Scale), Brief Visuospatial Memory Test Revised (BVMT-R), Trail Making Test B [TMT-B], Verbal Fluency Test (from D-KEFS), Color-Word Interference Test [Stroop test, from D-KEFS]).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cortical thickness measures</measure>
      <time_frame>At baseline, at 24 weeks after the start of the intervention</time_frame>
      <description>Change in cortical thickness (mm) in the prefrontal cortex and precuneus.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fractional anisotropy</measure>
      <time_frame>At baseline, at 24 weeks after the start of the intervention</time_frame>
      <description>Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resting-state measures</measure>
      <time_frame>At baseline, at 24 weeks after the start of the intervention</time_frame>
      <description>Change in the ratio between segregation and integration within and between the default-mode network and the limbic network during resting-state as measured with functional connectivity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GABA/glutamate ratio from magnetic resonance spectroscopy</measure>
      <time_frame>At baseline, at 24 weeks after the start of the intervention</time_frame>
      <description>Change in the GABA/glutamate ratio in the anterior cingulate cortex.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-mediated association between changes in sleep and cognition</measure>
      <time_frame>At 10-12 weeks and at 24 weeks after the start of the intervention</time_frame>
      <description>Mediation estimate of the extent to which exposure to eCBTi+ explains the association between improved sleep and improved cognition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction from System Usability Scale</measure>
      <time_frame>At 10-12 weeks after the start of the intervention</time_frame>
      <description>Score on the System Usability Scale, reflecting the degree to which participants were satisfied with the eCBTi+ and the control intervention. Percentage ranging between 0 and 100%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Technology acceptance</measure>
      <time_frame>At 10-12 weeks after the start of the intervention</time_frame>
      <description>Score on the extended version of the Technology Acceptance Model-2 reflecting th degree to which participants use and intend to use the eCBTi+ (and control intervention) as implemented on e-SPACE. Each process influencing technology acceptance is scored on a 7-point Likert scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to treatment</measure>
      <time_frame>At 10-12 weeks after the start of the intervention</time_frame>
      <description>Number of modules completed as a measure of treatment adherence</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">275</enrollment>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>online cognitive behavioral therapy for insomnia, anxiety and depression</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week</description>
    </arm_group>
    <arm_group>
      <arm_group_label>online intervention on nutrition and communication in older age</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>cognitive behavioral therapy for sleep, anxiety, and depression</intervention_name>
      <description>This intervention addresses insomnia, anxiety and depression via modules covering all the core CBTi components: psychoeducation about insomnia, relaxation, cognitive restructuring, stimulus control, sleep restriction and stress management; as well as psychoeducation about anxiety and low mood, behavioral activation strategies, and strategies to better manage ruminations. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings.</description>
      <arm_group_label>online cognitive behavioral therapy for insomnia, anxiety and depression</arm_group_label>
      <other_name>eCBTi+</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>education about healthy nutrition habits and communication in older age</intervention_name>
      <description>This intervention addresses healthy nutrition habits as well as communication and aging. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings</description>
      <arm_group_label>online intervention on nutrition and communication in older age</arm_group_label>
      <other_name>active control</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion&#xD;
  &#xD;
            -  age 60 years or older at the time of enrolment&#xD;
  &#xD;
            -  DSM-5 criteria for insomnia disorder (Sleep Condition Indicator, SCI ≤ 16)&#xD;
  &#xD;
            -  subjective memory decline&#xD;
  &#xD;
            -  ability to read and understand French or English&#xD;
  &#xD;
            -  ability to use a smartphone or tablet, and access to home internet connection&#xD;
  &#xD;
            -  If on hypnotic or psychotropic medication, being on stable dosage for at least 2&#xD;
               months prior to study entry&#xD;
  &#xD;
          Exclusion&#xD;
  &#xD;
            -  located outside of Québec or Ontario&#xD;
  &#xD;
            -  current hospitalization or planned major surgery&#xD;
  &#xD;
            -  uncorrected severe hearing or vision impairment&#xD;
  &#xD;
            -  reported diagnosis of major neurocognitive disorder or mild cognitive impairment (MCI)&#xD;
  &#xD;
            -  performance suggestive of major neurocognitive disorder or MCI on T-MoCA &lt; 17&#xD;
  &#xD;
            -  reported diagnosis of schizophrenia or bipolar disorder&#xD;
  &#xD;
            -  reported diagnosis or positive screen on the MINI for psychotic or bipolar disorders&#xD;
  &#xD;
            -  high suicidal risk, as assessed by the modified Columbia-Suicide Severity Rating Scale&#xD;
  &#xD;
            -  reported diagnosis or positive screening for another untreated sleep disorder (e.g.,&#xD;
               sleep disordered breathing (OSA), REM sleep behavior disorder (RBD), restless legs&#xD;
               syndrome (RLS); individuals with treated and controlled OSA or RLS will not be&#xD;
               excluded)&#xD;
  &#xD;
            -  apnea-hypopnea index &gt;10 on a level 3 home sleep apnea test or residual AHI &gt;10 for&#xD;
               individuals on CPAP&#xD;
  &#xD;
            -  current shift work&#xD;
  &#xD;
            -  currently receiving CBT&#xD;
  &#xD;
            -  frequent alcohol consumption (&gt;10 glasses/week or 3times/week), or use of alcohol&#xD;
               3x/week for sleep, or use of cannabis (more than once a week) or illicit drugs (more&#xD;
               than once a month)&#xD;
  &#xD;
            -  smoking more than 10 cigarettes/day&#xD;
  &#xD;
          Additional exclusion criteria for neuroimaging&#xD;
  &#xD;
            -  psychotropic (including hypnotic) medication in the past 2 weeks&#xD;
  &#xD;
            -  contraindications for MRI (e.g., pacemaker, metallic implant, claustrophobia)&#xD;
  &#xD;
            -  unable or unwilling to come to one of the participating MRI centers (Montreal, Ottawa)&#xD;
  &#xD;
            -  medical conditions likely to affect sleep; in particular:&#xD;
  &#xD;
            -  current neurological disorder (e.g., epilepsy with any seizure in the past year,&#xD;
               concussion in the past 3 months, multiple sclerosis, Parkinson's disease)&#xD;
  &#xD;
            -  past history of brain lesion (e.g., brain hemorrhage, brain tumor, any condition&#xD;
               having required brain surgery)&#xD;
  &#xD;
            -  major surgery (i.e., requiring general anesthesia) in the past 3 months&#xD;
  &#xD;
            -  untreated thyroid disorder&#xD;
  &#xD;
            -  chronic pain syndrome self-reported as interfering with sleep (e.g., migraine,&#xD;
               fibromyalgia, rheumatoid arthritis)&#xD;
  &#xD;
            -  recent and severe infection in the past 3 months (e.g., pneumonia, kidney infection)&#xD;
  &#xD;
            -  active cancer or treated cancer with post-cancer treatment for less than 2 years&#xD;
  &#xD;
          Inclusion/exclusion criteria for good sleepers Twenty-five good sleepers without cognitive&#xD;
          complaint will be recruited as controls for the MRI session following the same criteria&#xD;
          described above, except that SCI ≥ 17, not meeting the diagnostic criteria for chronic&#xD;
          insomnia as assessed by the insomnia module of the SCID and no subjective memory decline.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Thien Thanh Dang-Vu, MD PhD</last_name>
      <phone>+1 (514) 340-3540</phone>
      <phone_ext>3540</phone_ext>
      <email>tt.dangvu@concordia.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rebecca Robillard, PhD</last_name>
      <phone>+1 (613) 722-6521</phone>
      <phone_ext>6279</phone_ext>
      <email>rebecca.robillard@uottawa.ca</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal</investigator_affiliation>
      <investigator_full_name>Thien Thanh Dang-Vu</investigator_full_name>
      <investigator_title>Professor, Neurologist; Director, Sleep, Cognition &amp; Neuroimaging Laboratory (SCNLab)</investigator_title>
    </responsible_party>
    <keyword>insomnia</keyword>
    <keyword>cognition</keyword>
    <keyword>mental health</keyword>
    <keyword>subjective memory decline</keyword>
    <keyword>sleep</keyword>
    <keyword>online CBT</keyword>
    <keyword>older adults</keyword>
    <keyword>anxiety</keyword>
    <keyword>depression</keyword>
    <keyword>executive functions</keyword>
    <keyword>electroencephalography</keyword>
    <keyword>magnetic resonance imaging</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032377
  org study id: BH210177
  nct id: NCT06032377
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled clinical trial is to assess a novel
        cognitive-behavioral program for sleep and mental health using a multidomain web platform
        (eCBTi+) in participants with insomnia and subjective memory decline. The main questions it
        aims to answer are:
  
          -  Whether the eCBTi+ intervention improves sleep (subjective: Insomnia severity index
             [ISI], objective: EEG-based sleep efficiency) sleep and mental health (Geriatric Anxiety
             Index [GAI] and Geriatric Depression Scale [GDS]) compared to the control intervention
  
          -  Whether the eCBTi+ intervention improves cognitive abilities (subjective: Everyday
             Cognition [ECog], objective: CANTAB executive functions composite score) compared to the
             control intervention
  Participants with insomnia disorder will complete:
  
          -  A phone interview
  
          -  Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring
             devices)
  
          -  9 nights of at-home polysomnography with an EEG headband (3 times x 3 nights)
  
          -  42 sleep diaries (3 times x 14 days)
  
          -  42 days wearing an actigraphy device (3 times x 14 days)
  
          -  Online questionnaires
  
          -  3 cognitive testing sessions
  
          -  10 modules of online information on health, over the course of 10 weeks
  
          -  In MRI subgroup: 2 in-person testing
  
        Good sleeper participants will complete:
  
          -  A phone interview
  
          -  Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring
             devices)
  
          -  3 nights of at-home polysomnography with an EEG headband
  
          -  14 sleep diaries
  
          -  14 days wearing an actigraphy device
  
          -  Online questionnaires
  
          -  1 cognitive testing session
  
          -  1 in person session for MRI.
  
        In addition, researchers will compare outcomes from participants with insomnia and subjective
        memory decline to a group of good sleepers to have normative values for imaging data.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants with insomnia and subjective memory decline are randomized into 2 groups with a 1:1 allocation ratio, after the pre-treatment assessment. Allocation will be stratified based on a composite mental health score. An assessment post-intervention will occur 10 weeks after the start of the intervention and a follow-up assessment 24 weeks after the start of the intervention.
  One group will receive the online CBT for sleep and mental health after the baseline assessment and the other group will receive the control intervention. The group receiving the control intervention will access the CBT intervention after completion of the study.
  A good sleepers group, matched on age and gender, will also be recruited and assessed at baseline only to provide a normative reference group.
  A subgroup of participants and the good sleepers group will undergo MRI and classical neuropsychological testing at baseline and 24 weeks after the start of the intervention.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Insomnia severity index
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.
  measure: Subjective cognitive abilities based on the everyday cognition questionnaire
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Everyday cognition Questionnaire (ECog) total score as well as number of items with a score ≥ 3. The ECog comprises 39 items and total score corresponds to the sum of all completed items, divided by the number of items completed; thus, total scores range from 1-4. Higher score means more severe cognitive impairment.
  measure: Objective cognitive performance based on a composite score for executive functions from the CANTAB
  time frame: At baseline and at 24 weeks after the start of the intervention
  description: Change in the Cambridge Neuropsychological Test Automated Battery (CANTAB) executive functions composite score (Intra-Extra Dimensional Set Shift [IED] and Stocking of Cambridge [SOC], ranging from 0 to 100 with higher scores reflecting poorer executive functions.
  measure: Geriatric anxiety index
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.
  measure: Geriatric depression scale
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.
  measure: Sleep quality based on the Pittsburgh sleep quality index
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Pittsburgh sleep quality index. PSQI scores range from 0 to 21, higher scores mean worse sleep quality.
  measure: Objective sleep measures based on actigraphy: Sleep Efficiency
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Sleep Efficiency (SE) from actigraphs. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
  measure: Objective sleep measures based on actigraphy: Sleep Latency
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Sleep Latency (SL) from actigraphs. Sleep latency in minutes, greater values mean longer time to fall asleep.
  measure: Objective sleep measures based on actigraphy: Total Sleep Time
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Total Sleep Time (TST) from actigraphs. Total Sleep Time in minutes, greater values mean longer time spent asleep.
  measure: Objective sleep measures based on actigraphy: Wake After Sleep Onset
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Wake After Sleep Onset (WASO) from actigraphs. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
  measure: Objective sleep measures based on EEG: Sleep Efficiency
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Sleep Efficiency (SE) from EEG. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
  measure: Objective sleep measures based on EEG: Sleep Latency
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Sleep Latency (SL) from EEG. Sleep latency in minutes, greater values mean longer time to fall asleep
  measure: Objective sleep measures based on EEG: Total Sleep Time
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Total Sleep Time (TST) from EEG. Total Sleep Time in minutes, greater values mean longer time spent asleep.
  measure: Objective sleep measures based on EEG: Wake After Sleep Onset
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Wake After Sleep Onset (WASO) from EEG. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
  measure: Objective sleep measures based on EEG: Slow Wave Activity
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Slow Wave Activity (SWA) power density from EEG.
  measure: Objective sleep measures based on EEG: Slow Wave Sleep
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Slow Wave Sleep (SWS) from EEG. Slow Wave Sleep in minutes, greater values mean longer time spent in Slow Wave Sleep.
  measure: Subjective sleep measures based on sleep diaries: Sleep Efficiency
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Sleep Efficiency (SE) from sleep diaries. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
  measure: Subjective sleep measures based on sleep diaries: Sleep Latency
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Sleep Latency (SL) from sleep diaries. Sleep latency in minutes, greater values mean longer time to fall asleep.
  measure: Subjective sleep measures based on sleep diaries: Total Sleep Time
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Total Sleep Time (TST) from sleep diaries. Total Sleep Time in minutes, greater values mean longer time spent asleep.
  measure: Subjective sleep measures based on sleep diaries: Wake After Sleep Onset
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Wake After Sleep Onset (WASO) from sleep diaries. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
  measure: Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Rapid Visual Information Processing RVP - A' (sensitivity to the target sequence) and probability of false alarm (range: 0.00 - 1.00; bad to good)].
  measure: Cognitive performances from the CANTAB: Spatial Span (SSP)
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Spatial Span [SSP - Forward/Reverse Span Lengths (range: 2-9; bad to good]
  measure: Cognitive performances from the CANTAB: Spatial Working Memory (SWM)
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Spatial Working Memory [SWM - Number of times the subject incorrectly revisits a box in which a token has previously been found (range: 0 - ∞; good to bad)].
  measure: Cognitive performances from the CANTAB: Paired Associates Learning (PAL)
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Paired Associates Learning [PAL - Total errors adjusted (range: 0 - 70; good to bad; First attempt memory score (range: 0-20; bad to good)]
  measure: Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Pattern Recognition Memory [PRM - Percent correct immediate/delayed (range: 0-100; bad to good)].
  measure: Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Intra-Extra Dimensional Set Shift, IED - number of times that the subject failed to select the stimulus compatible with the current rule on the stage where the extra-dimensional shift occurs (range: 0-50; good to bad); Total errors adjusted (range: 0-402; good to bad)
  measure: Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Stocking of Cambridge, SOC - Number of problems successfully completed in the minimum possible number of moves (range: 0 - 12; bad to good); Mean number of moves required to complete problems (range: 5 - 12; good to bad); Initial thinking time median (range: 0 ms to ∞; longer times may indicate better planning efforts
  measure: Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)
  time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
  description: Change in Emotional Bias Task (EBT) subscales from the CANTAB [EBT - proportion of trials rated as 'Happy' (range: 0-15, bad to good)].
  measure: Memory encoding fMRI activations
  time frame: At baseline, at 24 weeks after the start of the intervention
  description: Change in fMRI activation level (arbitrary units) in the hippocampus, temporal lobe and prefrontal cortex during the memory encoding task.
  measure: Cognitive performance (classical neuropsychological tests)
  time frame: At baseline, at 24 weeks after the start of the intervention
  description: all subscales from classical neuropsychological test battery (Trail Making Test A [TMT-A], Digit Symbol Substitution test (WAIS), Boston Naming Test, Digit Span - forward and backward (WAIS), Rey Auditory Verbal Learning test, Logical Memory I and II (Wechsler Memory Scale), Brief Visuospatial Memory Test Revised (BVMT-R), Trail Making Test B [TMT-B], Verbal Fluency Test (from D-KEFS), Color-Word Interference Test [Stroop test, from D-KEFS]).
  measure: Cortical thickness measures
  time frame: At baseline, at 24 weeks after the start of the intervention
  description: Change in cortical thickness (mm) in the prefrontal cortex and precuneus.
  measure: Fractional anisotropy
  time frame: At baseline, at 24 weeks after the start of the intervention
  description: Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.
  measure: Resting-state measures
  time frame: At baseline, at 24 weeks after the start of the intervention
  description: Change in the ratio between segregation and integration within and between the default-mode network and the limbic network during resting-state as measured with functional connectivity.
  measure: GABA/glutamate ratio from magnetic resonance spectroscopy
  time frame: At baseline, at 24 weeks after the start of the intervention
  description: Change in the GABA/glutamate ratio in the anterior cingulate cortex.
  measure: Treatment-mediated association between changes in sleep and cognition
  time frame: At 10-12 weeks and at 24 weeks after the start of the intervention
  description: Mediation estimate of the extent to which exposure to eCBTi+ explains the association between improved sleep and improved cognition
  measure: Satisfaction from System Usability Scale
  time frame: At 10-12 weeks after the start of the intervention
  description: Score on the System Usability Scale, reflecting the degree to which participants were satisfied with the eCBTi+ and the control intervention. Percentage ranging between 0 and 100%.
  measure: Technology acceptance
  time frame: At 10-12 weeks after the start of the intervention
  description: Score on the extended version of the Technology Acceptance Model-2 reflecting th degree to which participants use and intend to use the eCBTi+ (and control intervention) as implemented on e-SPACE. Each process influencing technology acceptance is scored on a 7-point Likert scale.
  measure: Adherence to treatment
  time frame: At 10-12 weeks after the start of the intervention
  description: Number of modules completed as a measure of treatment adherence
  arm group label: online cognitive behavioral therapy for insomnia, anxiety and depression
  arm group type: Experimental
  description: 10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week
  arm group label: online intervention on nutrition and communication in older age
  arm group type: Active Comparator
  description: 10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week
  intervention type: Behavioral
  intervention name: cognitive behavioral therapy for sleep, anxiety, and depression
  description: This intervention addresses insomnia, anxiety and depression via modules covering all the core CBTi components: psychoeducation about insomnia, relaxation, cognitive restructuring, stimulus control, sleep restriction and stress management; as well as psychoeducation about anxiety and low mood, behavioral activation strategies, and strategies to better manage ruminations. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings.
  arm group label: online cognitive behavioral therapy for insomnia, anxiety and depression
  other name: eCBTi+
  intervention type: Behavioral
  intervention name: education about healthy nutrition habits and communication in older age
  description: This intervention addresses healthy nutrition habits as well as communication and aging. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings
  arm group label: online intervention on nutrition and communication in older age
  other name: active control
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Thien Thanh Dang-Vu, MD PhD
  phone: +1 (514) 340-3540
  phone ext: 3540
  email: tt.dangvu@concordia.ca
  last name: Rebecca Robillard, PhD
  phone: +1 (613) 722-6521
  phone ext: 6279
  email: rebecca.robillard@uottawa.ca
  responsible party type: Principal Investigator
  investigator affiliation: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
  investigator full name: Thien Thanh Dang-Vu
  investigator title: Professor, Neurologist; Director, Sleep, Cognition & Neuroimaging Laboratory (SCNLab)
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: Undecided