Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT03250468
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03250468
Study Brief:
Protocol Section:
NCT03250468