<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/NCT03250468</url>
  </required_header>
  <id_info>
    <org_study_id>6997</org_study_id>
    <nct_id>NCT03250468</nct_id>
  </id_info>
  <brief_title>Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients</brief_title>
  <official_title>Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research aims:&#xD;
&#xD;
        1. To determine if participation in a group-based cognitive behavioural therapy&#xD;
           intervention (CBT-I) intervention results in improved sleep quality.&#xD;
&#xD;
        2. To determine if participation in a group-based CBT-I intervention results in improved&#xD;
           cardiovascular disease risk factors, and if the CBT-I intervention moderates that&#xD;
           relationship.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease affects 5% of the population and almost 20% of those meet the criteria&#xD;
      for insomnia; twice as many as in the general population. Patients with cardiovascular&#xD;
      disease and insomnia have been found to have elevated rates of anxiety and depression, which&#xD;
      in turn places individuals at further cardiovascular risk via physiological pathways like&#xD;
      increased blood pressure and/or vascular inflammation. Further, insomnia has been linked with&#xD;
      negative health outcomes that exacerbate risk, including obesity, hypertension, and future&#xD;
      acute myocardial infarction. Given the negative impact of poor sleep on cardiac health, some&#xD;
      have argued that insomnia should now be included in the top 10 modifiable risk factors for&#xD;
      cardiovascular disease.&#xD;
&#xD;
      Currently the best treatment for insomnia is a group-based cognitive behavioural therapy&#xD;
      intervention (CBT-I); this intervention is more effective than pharmacotherapy. Evidence&#xD;
      shows that CBT-I produces significant improvements after 6 weeks of intervention and&#xD;
      improvements continue over the long term. This intervention program includes specific&#xD;
      cognitive therapy exercises aimed at maladaptive thoughts about sleep, behaviour change&#xD;
      techniques, and relaxation strategies (e.g., mindfulness, deep breathing); it also provides a&#xD;
      supportive environment for individuals to discuss their sleep difficulties, allowing them to&#xD;
      feel normalized and less isolated. For most people with insomnia however, their disorder goes&#xD;
      untreated, leaving individuals at higher risk for affective disorders (e.g., depression),&#xD;
      cardiovascular disease, and poorer quality of life. This lack of treatment is widespread and&#xD;
      systemic; patients who want help with insomnia face a dearth of information about treatment,&#xD;
      actual access to treatment and affordable services.&#xD;
&#xD;
      The proposed study is the first evaluation of a comprehensive CBT-I intervention designed for&#xD;
      cardiac patients. Of note, the proposed study will be the first to evaluate the impact of&#xD;
      this intervention on cardiovascular outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor follow/up rates and data.&#xD;
  </why_stopped>
  <start_date type="Actual">April 19, 2018</start_date>
  <completion_date type="Actual">March 2, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Through study completion, up to 3 months</time_frame>
    <description>Sleep quality will be measured using the Consensus Sleep Diary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Symptoms</measure>
    <time_frame>Through study completion, up to 3 months</time_frame>
    <description>Sleep symptoms will be measured using the Insomnia Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleepiness</measure>
    <time_frame>Through study completion, up to 3 months</time_frame>
    <description>The widely used Epworth Sleepiness Scale will be used to measure levels of sleepiness .experienced by patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity</measure>
    <time_frame>Through study completion, up to 3 months</time_frame>
    <description>Participants will wear an ActiGraph GTX3 accelerometer (ActiGraph, Pensacola, Florida) to assess sleep and physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Health</measure>
    <time_frame>Through study completion, up to 3 months</time_frame>
    <description>Both symptoms and severity of anxiety and depression will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Through study completion, up to 3 months</time_frame>
    <description>Patient quality of life will be measured using the 36-item short-form health survey (SF-36; version 1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Risk Factors</measure>
    <time_frame>Through study completion, up to 3 months</time_frame>
    <description>Cardiovascular disease diagnosis, fasting blood glucose concentration, triglycerides, glycated hemoglobin (HbA1c), cholesterol (High-density lipoprotein ratio</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Insomnia</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>CBT-I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to receive the intervention will attend 6 weekly group-based CBT-I sessions. Each 90-minute group will include 6-12 participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The wait-list control group will receive treatment as per our standard cardiac rehabilitation program. After completion of the 3-month follow-up questionnaire, wait-list control participants may take part in the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-I</intervention_name>
    <description>Each weekly session will focus on several psychological and behavioural techniques that include sleep restriction, relaxation strategies, cognitive therapy, stimulus control therapy, and education about proper sleep hygiene.</description>
    <arm_group_label>CBT-I</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sleep disturbance as indicated by a score on the Insomnia Severity Index (ISI) of 8 or&#xD;
             above.&#xD;
&#xD;
          -  Enrolled in the cardiac rehabilitation program offered by the University of Ottawa&#xD;
             Heart Institute.&#xD;
&#xD;
          -  Willing to be randomized.&#xD;
&#xD;
          -  Willing to wear a monitor that tracks sleep and physical activity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated or undiagnosed obstructive sleep apnea (as per standard cardiac&#xD;
             rehabilitation intake assessment, patients with a score of 5 or above on the STOP-BANG&#xD;
             (a brief assessment for sleep apnea) will be referred for a sleep assessment by a&#xD;
             cardiac rehabilitation physician).&#xD;
&#xD;
          -  Unable to converse in English (i.e., while patient materials and questionnaires will&#xD;
             be offered in both English and French, the intervention is only offered in English).&#xD;
&#xD;
          -  Unable to provide written, informed consent.&#xD;
&#xD;
          -  Unable to attend 6 weeks of onsite CBT-I intervention.&#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>Heather Tulloch, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical, Health, and Rehabilitation Psychologist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>April 20, 2020</last_update_submitted>
  <last_update_submitted_qc>April 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ottawa Heart Institute Research Corporation</investigator_affiliation>
    <investigator_full_name>Heather Tulloch</investigator_full_name>
    <investigator_title>Clinical Psychologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Cardiovascular Diseases</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/NCT03250468
org study id: 6997
nct id: NCT03250468
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Research aims:

        1. To determine if participation in a group-based cognitive behavioural therapy
           intervention (CBT-I) intervention results in improved sleep quality.

        2. To determine if participation in a group-based CBT-I intervention results in improved
           cardiovascular disease risk factors, and if the CBT-I intervention moderates that
           relationship.
Cardiovascular disease affects 5% of the population and almost 20% of those meet the criteria
      for insomnia; twice as many as in the general population. Patients with cardiovascular
      disease and insomnia have been found to have elevated rates of anxiety and depression, which
      in turn places individuals at further cardiovascular risk via physiological pathways like
      increased blood pressure and/or vascular inflammation. Further, insomnia has been linked with
      negative health outcomes that exacerbate risk, including obesity, hypertension, and future
      acute myocardial infarction. Given the negative impact of poor sleep on cardiac health, some
      have argued that insomnia should now be included in the top 10 modifiable risk factors for
      cardiovascular disease.

      Currently the best treatment for insomnia is a group-based cognitive behavioural therapy
      intervention (CBT-I); this intervention is more effective than pharmacotherapy. Evidence
      shows that CBT-I produces significant improvements after 6 weeks of intervention and
      improvements continue over the long term. This intervention program includes specific
      cognitive therapy exercises aimed at maladaptive thoughts about sleep, behaviour change
      techniques, and relaxation strategies (e.g., mindfulness, deep breathing); it also provides a
      supportive environment for individuals to discuss their sleep difficulties, allowing them to
      feel normalized and less isolated. For most people with insomnia however, their disorder goes
      untreated, leaving individuals at higher risk for affective disorders (e.g., depression),
      cardiovascular disease, and poorer quality of life. This lack of treatment is widespread and
      systemic; patients who want help with insomnia face a dearth of information about treatment,
      actual access to treatment and affordable services.

      The proposed study is the first evaluation of a comprehensive CBT-I intervention designed for
      cardiac patients. Of note, the proposed study will be the first to evaluate the impact of
      this intervention on cardiovascular outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Sleep Quality
time frame: Through study completion, up to 3 months
description: Sleep quality will be measured using the Consensus Sleep Diary.
measure: Sleep Symptoms
time frame: Through study completion, up to 3 months
description: Sleep symptoms will be measured using the Insomnia Severity Index
measure: Sleepiness
time frame: Through study completion, up to 3 months
description: The widely used Epworth Sleepiness Scale will be used to measure levels of sleepiness .experienced by patients
measure: Activity
time frame: Through study completion, up to 3 months
description: Participants will wear an ActiGraph GTX3 accelerometer (ActiGraph, Pensacola, Florida) to assess sleep and physical activity
measure: Mental Health
time frame: Through study completion, up to 3 months
description: Both symptoms and severity of anxiety and depression will be measured
measure: Quality of life
time frame: Through study completion, up to 3 months
description: Patient quality of life will be measured using the 36-item short-form health survey (SF-36; version 1)
measure: Cardiovascular Risk Factors
time frame: Through study completion, up to 3 months
description: Cardiovascular disease diagnosis, fasting blood glucose concentration, triglycerides, glycated hemoglobin (HbA1c), cholesterol (High-density lipoprotein ratio
arm group label: CBT-I
arm group type: Experimental
description: Participants randomized to receive the intervention will attend 6 weekly group-based CBT-I sessions. Each 90-minute group will include 6-12 participants.
arm group label: Wait-list control
arm group type: No Intervention
description: The wait-list control group will receive treatment as per our standard cardiac rehabilitation program. After completion of the 3-month follow-up questionnaire, wait-list control participants may take part in the intervention.
intervention type: Behavioral
intervention name: CBT-I
description: Each weekly session will focus on several psychological and behavioural techniques that include sleep restriction, relaxation strategies, cognitive therapy, stimulus control therapy, and education about proper sleep hygiene.
arm group label: CBT-I
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heather Tulloch, Ph.D
role: Principal Investigator
affiliation: Clinical, Health, and Rehabilitation Psychologist
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Ottawa Heart Institute Research Corporation
investigator full name: Heather Tulloch
investigator title: Clinical Psychologist
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Cardiovascular Diseases