Improving Sleep for Healthy Hearts

Completed · Not applicable

Conditions studied: Insomnia, Coronary Heart Disease

In brief

This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date).

Key facts

Study ID

NCT02848859

Run by

Brigham and Women's Hospital

People needed

34

Starts

2015-03-01

Expected to finish

2016-12-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• meet criteria for at least mild insomnia based on the Insomnia Severity Index questionnaire results
• have established coronary disease defined by: a) prior myocardial infarction or a coronary artery revascularization procedure; b) angiographically documented stenosis (>70%) of a major coronary artery; or c) prior ischemic stroke without major functional impairment.
• minimum age of 18 years old.

You may not qualify if…

• no daily access to a computer with an internet connection
• visual impairment preventing use of a computer
• inability to read English
• severe uncontrolled medical or psychiatric problems
• heart failure with reduced ejection fraction <35%
• high depressive symptoms (PHQ > 15)
• drowsy driving
• >3 days per week use of hypnotic medications
• known untreated sleep disordered breathing, narcolepsy, or restless leg syndrome
• shift-workers
• prior exposure to CBT-I treatment
• dialysis patient

Where it is running

• Brigham and Womens Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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