Improving Sleep for Healthy Hearts

Insomnia Clinical Trial

Official title:

Improving Sleep for Healthy Hearts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848859
• Other study ID #: 2014P000845
• Status: Completed
• Phase: N/A
• First received: July 22, 2016
• Last updated: February 22, 2017
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

For this pilot study, the investigators will recruit up to 30 participants with insomnia and coronary heart disease. Another 30 patients will be recruited from another institution. Patients will be screened with a modified version of the Insomnia Severity Index (ISI), a brief self-report instrument validated for identifying insomnia. The investigators will modify the ISI to include exclusionary criteria. The investigators will randomize participants to 6 weeks of access to web based cognitive behavioral therapy for insomnia (wCBT-I) using an internet based CBT-I program plus education provided through access to the Harvard Sleep Education web site (which provides general sleep education information only) compared to 6 weeks of access to the Harvard Sleep Education web site, followed by access to the web-CBT program (a wait list control group). The investigators will test the hypothesis that use of wCBT-I improves sleep quality and sleep duration as measured by sleep diaries and the ISI. A secondary goal of the study is to assess the recruitment yields, retention and adherence rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Insomnia
• Myocardial Ischemia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Go! to Sleep
This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.
• General Sleep Education
Providing patients information on healthy sleep and habits to promote healthy sleep.

Locations

Country	Name	City	State
United States	Brigham and Womens Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Insomnia Severity Index score at 6 weeks	It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.	At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Secondary	Change in sleep duration from baseline to 6 weeks	The investigators will use sleep diaries that participants fill out for 1 week at baseline and at 6 weeks to compare sleep duration between arms as well as at 12 weeks in the treatment arm only to assess duration of treatment effect.	At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Secondary	Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks	The investigators will use the Patient Health Questionnaire-8 to measure depressive symptoms	At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Secondary	Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks	The investigators will use the Epworth Sleepiness questionnaire to measure sleepiness.	At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Secondary	Change in blood pressure from baseline to 6 weeks	The investigators will measure seated blood pressure in triplicate and use the average of the latter two readings for blood pressure (taken at baseline and 6 week visits).	At baseline and at 6 weeks
Secondary	Change in heart rate from baseline to 6 weeks	The investigators will measure seated heart rate in triplicate and use the average of the latter two readings for heart rate(taken at baseline and 6 week visits).	At baseline and at 6 weeks
Secondary	Change in Quality of life at baseline and 6 weeks	The investigators will measure this using the Duke Health Profile, another validated questionnaire to measure quality of life.	At baseline, at 6 weeks, and in the treatment arm at 12 weeks.