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Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03250468
Recruitment Status : Terminated (Poor follow/up rates and data.)
First Posted : August 15, 2017
Last Update Posted : April 22, 2020
Information provided by (Responsible Party):
Heather Tulloch, Ottawa Heart Institute Research Corporation

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Insomnia Cardiovascular Diseases Behavioral: CBT-I Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients
Actual Study Start Date : April 19, 2018
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : March 2, 2020

Arm Intervention/treatment
Experimental: CBT-I
Participants randomized to receive the intervention will attend 6 weekly group-based CBT-I sessions. Each 90-minute group will include 6-12 participants.
Behavioral: CBT-I
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.

No Intervention: Wait-list control
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.

Primary Outcome Measures :
  1. Sleep Quality [ Time Frame: Through study completion, up to 3 months ]
    Sleep quality will be measured using the Consensus Sleep Diary.

Secondary Outcome Measures :
  1. Sleep Symptoms [ Time Frame: Through study completion, up to 3 months ]
    Sleep symptoms will be measured using the Insomnia Severity Index

  2. Sleepiness [ Time Frame: Through study completion, up to 3 months ]
    The widely used Epworth Sleepiness Scale will be used to measure levels of sleepiness .experienced by patients

  3. Activity [ Time Frame: Through study completion, up to 3 months ]
    Participants will wear an ActiGraph GTX3 accelerometer (ActiGraph, Pensacola, Florida) to assess sleep and physical activity

  4. Mental Health [ Time Frame: Through study completion, up to 3 months ]
    Both symptoms and severity of anxiety and depression will be measured

  5. Quality of life [ Time Frame: Through study completion, up to 3 months ]
    Patient quality of life will be measured using the 36-item short-form health survey (SF-36; version 1)

  6. Cardiovascular Risk Factors [ Time Frame: Through study completion, up to 3 months ]
    Cardiovascular disease diagnosis, fasting blood glucose concentration, triglycerides, glycated hemoglobin (HbA1c), cholesterol (High-density lipoprotein ratio

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sleep disturbance as indicated by a score on the Insomnia Severity Index (ISI) of 8 or above.
  • Enrolled in the cardiac rehabilitation program offered by the University of Ottawa Heart Institute.
  • Willing to be randomized.
  • Willing to wear a monitor that tracks sleep and physical activity.

Exclusion Criteria:

  • Untreated or undiagnosed obstructive sleep apnea (as per standard cardiac rehabilitation intake assessment, patients with a score of 5 or above on the STOP-BANG (a brief assessment for sleep apnea) will be referred for a sleep assessment by a cardiac rehabilitation physician).
  • Unable to converse in English (i.e., while patient materials and questionnaires will be offered in both English and French, the intervention is only offered in English).
  • Unable to provide written, informed consent.
  • Unable to attend 6 weeks of onsite CBT-I intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03250468

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Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
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Principal Investigator: Heather Tulloch, Ph.D Clinical, Health, and Rehabilitation Psychologist
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Responsible Party: Heather Tulloch, Clinical Psychologist, Ottawa Heart Institute Research Corporation Identifier: NCT03250468    
Other Study ID Numbers: 6997
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders