Status:
TERMINATED
Sleep to Your Heart's Content - Insomnia Intervention for Cardiac Patients
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Insomnia
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 insomni...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03250468
Start Date
April 19 2018
End Date
March 2 2020
Last Update
April 22 2020
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7