<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/NCT04473534</url>
  </required_header>
  <id_info>
    <org_study_id>2361</org_study_id>
    <nct_id>NCT04473534</nct_id>
  </id_info>
  <brief_title>Web Based CBT-I in Patients With OSA and Insomnia</brief_title>
  <official_title>Web Based Cognitive-behavioral Therapy in Patients With Obstructive Sleep Apnoea Syndrome and Insomnia: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituti Clinici Scientifici Maugeri SpA</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>
      Obstructive sleep apnea (OSA) and insomnia often occur in the same patient. Recent studies&#xD;
      have demonstrated the efficacy of cognitive behavioral therapy (CBT-I) in patients with&#xD;
      insomnia and OSA. Our aim is to verify the efficacy of web based CBT-I in patients with OSA&#xD;
      and insomnia and the effect of web based CBT-I on the acceptance and adherence to CPAP&#xD;
      (Continuous Positive Airway Pressure) therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea is one of the most common sleep disorders with high prevalence in&#xD;
      males sex, is often associated with insomnia. The presence of both sleep disorders generates&#xD;
      a vicious circle that exacerbates the clinical picture, makes difficult to accept and adhere&#xD;
      to CPAP therapy and increase cardiovascular risk. CBT-I is considered the best treatment for&#xD;
      insomnia and recent research has demonstrated the efficacy of CBT-I also when insomnia is&#xD;
      associated with OSA. After six month of treatment we will test the efficacy of web-based&#xD;
      CBT-I in patients with OSA and insomnia in comparison to one session of psycho education on&#xD;
      sleep, OSA, insomnia, the interaction among them and the influence on CPAP adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 10, 2021</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity</measure>
    <time_frame>Baseline</time_frame>
    <description>Assessed by Insomnia Severity Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insomnia Severity</measure>
    <time_frame>six months of CPAP use</time_frame>
    <description>Assessed by Insomnia Severity Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to CPAP therapy</measure>
    <time_frame>six months of use</time_frame>
    <description>Hours of CPAP use during sleep with download of data</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">57</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Arm of CBT-I treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Web cognitive behavioral therapy was administered before starting CPAP use by a psychologist expert in behavioral sleep medicine and expert in CBT-I. CBT-I was administered according to the same model and standard visual approach in patients with insomnia. Five sessions are scheduled: sleep psycho-education, sleep restriction, stimulus control, sleep hygiene and challenging beliefs and perception of sleep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm of psycho-education session</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm of control TAU (Treatment As Usual)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive TAU. Each patient will start to use CPAP after the diagnosis according to AASM (American Academy of Sleep Medicine) guideline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>web based cognitive-behavioral therapy</intervention_name>
    <description>one web session of psycho-education about sleep</description>
    <arm_group_label>Arm of CBT-I treatment</arm_group_label>
    <arm_group_label>Arm of psycho-education session</arm_group_label>
    <other_name>Arm of psycho-education session</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18&#xD;
&#xD;
          -  Apnea-Hypopnea Index (AHI) ≥5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complex sleep apnea&#xD;
&#xD;
          -  AHI &gt;35&#xD;
&#xD;
          -  Psychiatric comorbidies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fabio Rossato</name>
      <address>
        <city>Veruno</city>
        <state>Novara</state>
        <zip>28013</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabio Rossato, TNFP</last_name>
      <phone>0039-0322884959</phone>
      <email>fabio.rossato@icsmaugeri.it</email>
    </contact>
    <contact_backup>
      <last_name>Alberto Braghiroli, MD</last_name>
      <email>alberto.braghiroli@icsmaugeri.it</email>
    </contact_backup>
    <investigator>
      <last_name>Elisa Morrone, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Sweetman A, Lack L, Catcheside PG, Antic NA, Smith S, Chai-Coetzer CL, Douglas J, O'grady A, Dunn N, Robinson J, Paul D, Williamson P, McEvoy RD. Cognitive and behavioral therapy for insomnia increases the use of continuous positive airway pressure therapy in obstructive sleep apnea participants with comorbid insomnia: a randomized clinical trial. Sleep. 2019 Dec 24;42(12):zsz178. doi: 10.1093/sleep/zsz178.</citation>
    <PMID>31403168</PMID>
  </reference>
  <reference>
    <citation>Sweetman A, McEvoy RD, Smith S, Catcheside PG, Antic NA, Chai-Coetzer CL, Douglas J, O'Grady A, Dunn N, Robinson J, Paul D, Williamson P, Lack L. The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial. Sleep. 2020 Jul 13;43(7):zsaa002. doi: 10.1093/sleep/zsaa002.</citation>
    <PMID>31927569</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>February 25, 2021</last_update_submitted>
  <last_update_submitted_qc>February 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obstructive sleep apnea</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Web based CBT-I</keyword>
  <keyword>CPAP treatment</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04473534
org study id: 2361
nct id: NCT04473534
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea (OSA) and insomnia often occur in the same patient. Recent studies
      have demonstrated the efficacy of cognitive behavioral therapy (CBT-I) in patients with
      insomnia and OSA. Our aim is to verify the efficacy of web based CBT-I in patients with OSA
      and insomnia and the effect of web based CBT-I on the acceptance and adherence to CPAP
      (Continuous Positive Airway Pressure) therapy.
Obstructive sleep apnea is one of the most common sleep disorders with high prevalence in
      males sex, is often associated with insomnia. The presence of both sleep disorders generates
      a vicious circle that exacerbates the clinical picture, makes difficult to accept and adhere
      to CPAP therapy and increase cardiovascular risk. CBT-I is considered the best treatment for
      insomnia and recent research has demonstrated the efficacy of CBT-I also when insomnia is
      associated with OSA. After six month of treatment we will test the efficacy of web-based
      CBT-I in patients with OSA and insomnia in comparison to one session of psycho education on
      sleep, OSA, insomnia, the interaction among them and the influence on CPAP adherence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Insomnia Severity
time frame: Baseline
description: Assessed by Insomnia Severity Index
measure: Insomnia Severity
time frame: six months of CPAP use
description: Assessed by Insomnia Severity Index
measure: Adherence to CPAP therapy
time frame: six months of use
description: Hours of CPAP use during sleep with download of data
arm group label: Arm of CBT-I treatment
arm group type: Experimental
description: Web cognitive behavioral therapy was administered before starting CPAP use by a psychologist expert in behavioral sleep medicine and expert in CBT-I. CBT-I was administered according to the same model and standard visual approach in patients with insomnia. Five sessions are scheduled: sleep psycho-education, sleep restriction, stimulus control, sleep hygiene and challenging beliefs and perception of sleep.
arm group label: Arm of psycho-education session
arm group type: Experimental
description: Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use
arm group label: Arm of control TAU (Treatment As Usual)
arm group type: No Intervention
description: The control group will receive TAU. Each patient will start to use CPAP after the diagnosis according to AASM (American Academy of Sleep Medicine) guideline.
intervention type: Behavioral
intervention name: web based cognitive-behavioral therapy
description: one web session of psycho-education about sleep
arm group label: Arm of CBT-I treatment
arm group label: Arm of psycho-education session
other name: Arm of psycho-education session
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Italy
citation: Sweetman A, Lack L, Catcheside PG, Antic NA, Smith S, Chai-Coetzer CL, Douglas J, O'grady A, Dunn N, Robinson J, Paul D, Williamson P, McEvoy RD. Cognitive and behavioral therapy for insomnia increases the use of continuous positive airway pressure therapy in obstructive sleep apnea participants with comorbid insomnia: a randomized clinical trial. Sleep. 2019 Dec 24;42(12):zsz178. doi: 10.1093/sleep/zsz178.
PMID: 31403168
citation: Sweetman A, McEvoy RD, Smith S, Catcheside PG, Antic NA, Chai-Coetzer CL, Douglas J, O'Grady A, Dunn N, Robinson J, Paul D, Williamson P, Lack L. The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial. Sleep. 2020 Jul 13;43(7):zsaa002. doi: 10.1093/sleep/zsaa002.
PMID: 31927569
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No