<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/NCT02232204</url>
  </required_header>
  <id_info>
    <org_study_id>157-2008</org_study_id>
    <secondary_id>R21HL087831</secondary_id>
    <nct_id>NCT02232204</nct_id>
  </id_info>
  <brief_title>Sleep and Ventricular Arrhythmias Study</brief_title>
  <acronym>SAVE</acronym>
  <official_title>Sleep in Cardiac Patients With Implantable Cardioverter Defibrillators (ICD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-center, randomized controlled trial study design. Enrolled participants have&#xD;
      a cardiovascular condition for which they are undergoing implantable cardioverter&#xD;
      defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a&#xD;
      behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment&#xD;
      intervention period lasted 4 weeks with a telephone booster session administered at 3 month&#xD;
      follow-up. The objective of the study is to examine the impact of a brief therapy combining&#xD;
      established behavioral approaches to treating insomnia with novel components to target&#xD;
      negative cognitions and anxieties associated with cardiac disease and ICD implantation.&#xD;
      Primary patient outcomes include sleep, psychological functioning, daytime functioning,&#xD;
      cardiac functioning, cognitive performance, and ICD adjustment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be asked to review the informed consent form and consent to the study prior&#xD;
      to beginning any study procedure.&#xD;
&#xD;
      There are six phases of this study: (1) an in-person interview, (2) an in-home single night&#xD;
      sleep recording, (3) a two-week baseline period, (4) a 4-week treatment period, (5) a&#xD;
      follow-up period immediately after the completion of treatment, (6) and a two-week follow-up&#xD;
      period 3-months after the treatment period.&#xD;
&#xD;
      During the interview, participants will be asked questions about their sleep, cardiac, and&#xD;
      ICD history. Participants will then visit the University of Florida for a medical history and&#xD;
      will be connected to machinery to monitor their sleep. Participants will return home to sleep&#xD;
      while still connected to the machine and will return the machine to the University of Florida&#xD;
      the next day. A third visit will consist of completing questionnaires and a computerized&#xD;
      neurocognitive performance battery to assess several areas of cognitive functioning.&#xD;
      Participants will then go home and with brief daily diaries to complete for two weeks while&#xD;
      also wearing an actigraph (wristwatch-like device) that measures arm movements to detect&#xD;
      sleep/wake during that time.&#xD;
&#xD;
      Participants will then be randomized to (a) the brief cognitive behavioral therapy for&#xD;
      insomnia (CBTi) in ICD patients group or (b) the waitlist control group. The treatment&#xD;
      consists of 2 weeks of in-person therapy and 2 weeks of therapy conducted over the telephone.&#xD;
      Participants assigned to waitlist control will be offered therapy at no cost at the end of&#xD;
      the study. Throughout the 4 treatment weeks, participants in both groups will be asked to&#xD;
      complete daily sleep diaries.&#xD;
&#xD;
      A follow-up period consisting of two weeks, during which participants will wear the actigraph&#xD;
      and complete daily sleep diaries, will take place immediately after treatment completion.&#xD;
      Participants will travel to the University two times during this follow-up period in order to&#xD;
      pick-up and then return the actigraph and sleep diaries, and will once again complete the&#xD;
      questionnaires and neurocognitive testing battery at the end of the 2nd visit. A final&#xD;
      follow-up period will occur 3-months following treatment, which will involve visits to the&#xD;
      University to pick up the daily sleep diaries and actigraph for sleep monitoring, and then&#xD;
      returning these items after completion 2-weeks later. Upon returning the diary and actigraph,&#xD;
      participants will complete questionnaires and then be debriefed by study personnel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in subjective and objective sleep</measure>
    <time_frame>Change from baseline to the two study follow-ups (immediately and 3-months following treatment)</time_frame>
    <description>Sleep diary and actigraphy-derived sleep parameters (averaged over each 14-day data collection period at baseline, post-treatment, and at 3-month follow-up) including: time to fall asleep (sleep onset latency), wake time during the night (waketime after sleep onset), total sleep time, amount of time spent in bed sleeping (sleep efficiency), total nap time, and sleep quality rating.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in psychological functioning</measure>
    <time_frame>Change from baseline to the two follow-up periods (immediately and 3-months following treatment)</time_frame>
    <description>Changes in reported symptoms of anxiety and depression as assessed by questionnaires from baseline to immediately and 3 months following treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daytime functioning</measure>
    <time_frame>Change from baseline to the two follow-up periods (immediately and 3-months following treatment)</time_frame>
    <description>The change in reported insomnia impact, fatigue, and sleepiness as assessed by questionnaires from baseline to immediately and 3 months following treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Change from baseline to the two follow-up periods (immediately and 3-months following treatment)</time_frame>
    <description>The change in reported health-related quality of life as assessed by questionnaires from baseline to immediately and 3 months following treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac functioning</measure>
    <time_frame>Change from baseline to the two follow-up periods (immediately and 3-months following treatment)</time_frame>
    <description>The change in device-recorded incidence of ventricular arrhythmia from baseline to immediately and 3 months following treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in device adjustment</measure>
    <time_frame>Change from baseline to the two follow-up periods (immediately and 3-months following treatment</time_frame>
    <description>The change in reported shock anxiety and device-specific acceptance as assessed by questionnaires from baseline to immediately and 3 months following treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive functioning</measure>
    <time_frame>Change from baseline to immediately after treatment</time_frame>
    <description>The change in computer-recorded cognitive functioning in the domains of executive control, reasoning, working memory, attention, and reaction time as assessed from baseline to immediately following treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Cardiac Arrhythmia</condition>
  <condition>Implantable Defibrillator User</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>CBT for Insomnia in ICD Patients (CBT-I-ICD)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control (WLC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the WLC group will not receive any treatment between the baseline and post-treatment assessments. After the final follow-up assessment, they will be offered the opportunity to receive CBT-I-ICD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT for Insomnia in ICD Patients (CBT-I-ICD)</intervention_name>
    <description>Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations.</description>
    <arm_group_label>CBT for Insomnia in ICD Patients (CBT-I-ICD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current ICD implantation (single or dual lead ICD, ICD and pacemaker)&#xD;
&#xD;
          -  Diagnosis of insomnia&#xD;
&#xD;
          -  No sleep medications for at least 1 month, or stable on medications for at least 6&#xD;
             months&#xD;
&#xD;
          -  Willing to be randomly assigned to treatment&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sleep disorder other than insomnia&#xD;
&#xD;
          -  Significant medical condition other than cardiac disease&#xD;
&#xD;
          -  Severe untreated psychopathology&#xD;
&#xD;
          -  Neurological disorder&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina S McCrae, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida Aging</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>insomnia</keyword>
  <keyword>implantable cardioverter defibrillator</keyword>
  <keyword>cardiac arrhythmia</keyword>
  <keyword>cognitive behavioral treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02232204
org study id: 157-2008
secondary id: R21HL087831
nct id: NCT02232204
lead sponsor: 
collaborator: 
has dmc: No
This is a single-center, randomized controlled trial study design. Enrolled participants have
      a cardiovascular condition for which they are undergoing implantable cardioverter
      defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a
      behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment
      intervention period lasted 4 weeks with a telephone booster session administered at 3 month
      follow-up. The objective of the study is to examine the impact of a brief therapy combining
      established behavioral approaches to treating insomnia with novel components to target
      negative cognitions and anxieties associated with cardiac disease and ICD implantation.
      Primary patient outcomes include sleep, psychological functioning, daytime functioning,
      cardiac functioning, cognitive performance, and ICD adjustment.
Participants will be asked to review the informed consent form and consent to the study prior
      to beginning any study procedure.

      There are six phases of this study: (1) an in-person interview, (2) an in-home single night
      sleep recording, (3) a two-week baseline period, (4) a 4-week treatment period, (5) a
      follow-up period immediately after the completion of treatment, (6) and a two-week follow-up
      period 3-months after the treatment period.

      During the interview, participants will be asked questions about their sleep, cardiac, and
      ICD history. Participants will then visit the University of Florida for a medical history and
      will be connected to machinery to monitor their sleep. Participants will return home to sleep
      while still connected to the machine and will return the machine to the University of Florida
      the next day. A third visit will consist of completing questionnaires and a computerized
      neurocognitive performance battery to assess several areas of cognitive functioning.
      Participants will then go home and with brief daily diaries to complete for two weeks while
      also wearing an actigraph (wristwatch-like device) that measures arm movements to detect
      sleep/wake during that time.

      Participants will then be randomized to (a) the brief cognitive behavioral therapy for
      insomnia (CBTi) in ICD patients group or (b) the waitlist control group. The treatment
      consists of 2 weeks of in-person therapy and 2 weeks of therapy conducted over the telephone.
      Participants assigned to waitlist control will be offered therapy at no cost at the end of
      the study. Throughout the 4 treatment weeks, participants in both groups will be asked to
      complete daily sleep diaries.

      A follow-up period consisting of two weeks, during which participants will wear the actigraph
      and complete daily sleep diaries, will take place immediately after treatment completion.
      Participants will travel to the University two times during this follow-up period in order to
      pick-up and then return the actigraph and sleep diaries, and will once again complete the
      questionnaires and neurocognitive testing battery at the end of the 2nd visit. A final
      follow-up period will occur 3-months following treatment, which will involve visits to the
      University to pick up the daily sleep diaries and actigraph for sleep monitoring, and then
      returning these items after completion 2-weeks later. Upon returning the diary and actigraph,
      participants will complete questionnaires and then be debriefed by study personnel.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in subjective and objective sleep
time frame: Change from baseline to the two study follow-ups (immediately and 3-months following treatment)
description: Sleep diary and actigraphy-derived sleep parameters (averaged over each 14-day data collection period at baseline, post-treatment, and at 3-month follow-up) including: time to fall asleep (sleep onset latency), wake time during the night (waketime after sleep onset), total sleep time, amount of time spent in bed sleeping (sleep efficiency), total nap time, and sleep quality rating.
measure: Change in psychological functioning
time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
description: Changes in reported symptoms of anxiety and depression as assessed by questionnaires from baseline to immediately and 3 months following treatment.
measure: Change in daytime functioning
time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
description: The change in reported insomnia impact, fatigue, and sleepiness as assessed by questionnaires from baseline to immediately and 3 months following treatment.
measure: Change in quality of life
time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
description: The change in reported health-related quality of life as assessed by questionnaires from baseline to immediately and 3 months following treatment.
measure: Change in cardiac functioning
time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment)
description: The change in device-recorded incidence of ventricular arrhythmia from baseline to immediately and 3 months following treatment.
measure: Change in device adjustment
time frame: Change from baseline to the two follow-up periods (immediately and 3-months following treatment
description: The change in reported shock anxiety and device-specific acceptance as assessed by questionnaires from baseline to immediately and 3 months following treatment.
measure: Change in cognitive functioning
time frame: Change from baseline to immediately after treatment
description: The change in computer-recorded cognitive functioning in the domains of executive control, reasoning, working memory, attention, and reaction time as assessed from baseline to immediately following treatment.
arm group label: CBT for Insomnia in ICD Patients (CBT-I-ICD)
arm group type: Active Comparator
description: Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations.
arm group label: Waitlist Control (WLC)
arm group type: No Intervention
description: Participants in the WLC group will not receive any treatment between the baseline and post-treatment assessments. After the final follow-up assessment, they will be offered the opportunity to receive CBT-I-ICD.
intervention type: Behavioral
intervention name: CBT for Insomnia in ICD Patients (CBT-I-ICD)
description: Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations.
arm group label: CBT for Insomnia in ICD Patients (CBT-I-ICD)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina S McCrae, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Arrhythmias, Cardiac