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Improving Sleep for Healthy Hearts

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ClinicalTrials.gov Identifier: NCT02848859
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Susan Redline, Brigham and Women's Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Insomnia Coronary Heart Disease Behavioral: Go! to Sleep Behavioral: General Sleep Education Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Sleep for Healthy Hearts
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

Arm Intervention/treatment
Active Comparator: Intervention: Go! to Sleep
We are using a web-based cognitive behavioral therapy program called Go! to Sleep. Go! to Sleep is an interactive online program developed by specialists in Cleveland Clinic's Wellness Institute and Sleep Disorders Center. The program is a 6 week self-help program that uses cognitive behavioral therapy techniques that have been proven to be effective in decreasing symptoms of insomnia.
Behavioral: Go! to Sleep
This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.
Other Name: web-based cognitive behavioral therapy

Behavioral: General Sleep Education
Providing patients information on healthy sleep and habits to promote healthy sleep.

Placebo Comparator: General Sleep Hygiene Education
General Sleep Hygiene Education is the first step in the treatment of any sleep disorder. Both arms will have access to a Harvard sleep education web site that provides general information about sleep as well as sleep hygiene.
Behavioral: General Sleep Education
Providing patients information on healthy sleep and habits to promote healthy sleep.




Primary Outcome Measures :
  1. Change from baseline Insomnia Severity Index score at 6 weeks [ Time Frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks. ]
    It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.


Secondary Outcome Measures :
  1. Change in sleep duration from baseline to 6 weeks [ Time Frame: At baseline, at 6 weeks, and in the treatment arm at 12 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.

  2. Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks [ Time Frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks. ]
    The investigators will use the Patient Health Questionnaire-8 to measure depressive symptoms

  3. Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks [ Time Frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks. ]
    The investigators will use the Epworth Sleepiness questionnaire to measure sleepiness.

  4. Change in blood pressure from baseline to 6 weeks [ Time Frame: At baseline and at 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).

  5. Change in heart rate from baseline to 6 weeks [ Time Frame: At baseline and at 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).

  6. Change in Quality of life at baseline and 6 weeks [ Time Frame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks. ]
    The investigators will measure this using the Duke Health Profile, another validated questionnaire to measure quality of life.



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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02848859


Locations
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United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
The Cleveland Clinic
Investigators
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Principal Investigator: Susan Redline, MD, MPH Brigham and Women's Hospital
Study Director: Sogol Javaheri, MD, MA Brigham and Women's Hospital

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Responsible Party: Susan Redline, Senior Physician, Division of Sleep and Circadian Disorders, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02848859     History of Changes
Other Study ID Numbers: 2014P000845
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Susan Redline, Brigham and Women's Hospital:
cognitive behavioral therapy for insomnia
randomized controlled trial
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases