Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT02848859
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2016-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Sleep for Healthy Hearts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2016-07-22', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Insomnia Severity Index score at 6 weeks', 'timeFrame': 'At baseline, at 6 weeks, and in the treatment arm at 12 weeks.', 'description': 'It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in sleep duration from baseline to 6 weeks', 'timeFrame': 'At baseline, at 6 weeks, and in the treatment arm at 12 weeks.', 'description': '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.'}, {'measure': 'Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks', 'timeFrame': 'At baseline, at 6 weeks, and in the treatment arm at 12 weeks.', 'description': 'The investigators will use the Patient Health Questionnaire-8 to measure depressive symptoms'}, {'measure': 'Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks', 'timeFrame': 'At baseline, at 6 weeks, and in the treatment arm at 12 weeks.', 'description': 'The investigators will use the Epworth Sleepiness questionnaire to measure sleepiness.'}, {'measure': 'Change in blood pressure from baseline to 6 weeks', 'timeFrame': 'At baseline and at 6 weeks', 'description': '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).'}, {'measure': 'Change in heart rate from baseline to 6 weeks', 'timeFrame': 'At baseline and at 6 weeks', 'description': '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).'}, {'measure': 'Change in Quality of life at baseline and 6 weeks', 'timeFrame': 'At baseline, at 6 weeks, and in the treatment arm at 12 weeks.', 'description': 'The investigators will measure this using the Duke Health Profile, another validated questionnaire to measure quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cognitive behavioral therapy for insomnia', 'randomized controlled trial'], 'conditions': ['Insomnia', 'Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meet criteria for at least mild insomnia based on the Insomnia Severity Index questionnaire results\n* 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.\n* minimum age of 18 years old.\n\nExclusion Criteria:\n\n* no daily access to a computer with an internet connection\n* visual impairment preventing use of a computer\n* inability to read English\n* severe uncontrolled medical or psychiatric problems\n* heart failure with reduced ejection fraction \\<35%\n* high depressive symptoms (PHQ \\> 15)\n* drowsy driving\n* \\>3 days per week use of hypnotic medications\n* known untreated sleep disordered breathing, narcolepsy, or restless leg syndrome\n* shift-workers\n* prior exposure to CBT-I treatment\n* dialysis patient'}, 'identificationModule': {'nctId': 'NCT02848859', 'briefTitle': 'Improving Sleep for Healthy Hearts', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Improving Sleep for Healthy Hearts', 'orgStudyIdInfo': {'id': '2014P000845'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention: Go! to Sleep', 'description': "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.", 'interventionNames': ['Behavioral: Go! to Sleep', 'Behavioral: General Sleep Education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'General Sleep Hygiene Education', 'description': '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.', 'interventionNames': ['Behavioral: General Sleep Education']}], 'interventions': [{'name': 'Go! to Sleep', 'type': 'BEHAVIORAL', 'otherNames': ['web-based cognitive behavioral therapy'], 'description': 'This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.', 'armGroupLabels': ['Intervention: Go! to Sleep']}, {'name': 'General Sleep Education', 'type': 'BEHAVIORAL', 'description': 'Providing patients information on healthy sleep and habits to promote healthy sleep.', 'armGroupLabels': ['General Sleep Hygiene Education', 'Intervention: Go! to Sleep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Brigham and Womens Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Susan Redline, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Sogol Javaheri, MD, MA', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physician, Division of Sleep and Circadian Disorders', 'investigatorFullName': 'Susan Redline', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}