Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04077658
Status:
COMPLETED
Last Update Posted:
2020-08-24
First Post:
2019-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Heartmath Migraine Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial with intervention arm and waitlist control arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-09-03', 'lastUpdatePostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life', 'timeFrame': '8 Weeks', 'description': 'Measured by comparing the slope of reduction in MSQv2 scores'}], 'secondaryOutcomes': [{'measure': 'Change in depression', 'timeFrame': '8 Weeks', 'description': 'Measured using slope in reduction of Generalized Anxiety Disorder 7-item (GAD-7) scale. Average scores of 5-9: Mild; 10\\*-14:Moderate; \\>15:Severe'}, {'measure': 'Change in anxiety', 'timeFrame': '8 Weeks', 'description': 'Measured using slope of reduction in eight-item Patient Health Questionnaire depression scale (PHQ-8), The PHQ-8 uses a 4-point Likert scale to assess depressive symptoms. The score range is 0 to 27. Scores 5-9 indicate "mild" symptoms, 10-14 "moderate", and ≥20 "severe" depressive symptoms.'}, {'measure': 'Change insomnia', 'timeFrame': '8 Weeks', 'description': 'Measured using slope of reduction in Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HeartMath app', 'Inner Balance Sensor'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'This is a two arm study comparing smartphone based heart rate variability biofeedback using the HeartMath app and InnerBalance sensor to waitlist control on migraine quality of life.', 'detailedDescription': 'The primary objective of this study is to determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life. Investigators will also look:\n\n* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in depression in people with migraine.\n* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in anxiety in people with migraine.\n* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in insomnia in people with migraine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* International Classification of Headache Disorders (ICHD) 3 criteria for migraine\n* 4-20 headache days/month\n* Has not done behavioral therapy for migraine in the past year\n* Has a smartphone and willing to try HRV biofeedback using an app and ear monitor\n* English speaking\n* HS graduate or higher level of education\n* Patients must not make preventive medication changes for the course of the study. If patients just changed their preventive medication, they must wait a month before enrolling.\n\nExclusion Criteria:\n\n* Doing any form of behavioral therapy for pain in the past year'}, 'identificationModule': {'nctId': 'NCT04077658', 'briefTitle': 'Heartmath Migraine Study', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Pilot Single-center Randomized Controlled Study of the Effects of Smartphone Based Heart Rate Variability Biofeedback in People With Migraine', 'orgStudyIdInfo': {'id': '19-00479'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HeartMath', 'interventionNames': ['Behavioral: HeartMath']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control', 'interventionNames': ['Behavioral: HeartMath', 'Behavioral: Waitlist Control']}], 'interventions': [{'name': 'HeartMath', 'type': 'BEHAVIORAL', 'description': 'HeartMath is a program where individuals learn heart rate variability biofeedback. Essentially, they learn breathing exercises that reduce their heart rate. The HeartMath program will be administered via an application on the smartphone and ear monitor.', 'armGroupLabels': ['HeartMath', 'Waitlist Control']}, {'name': 'Waitlist Control', 'type': 'BEHAVIORAL', 'description': 'Standard of Care Migraine Treatment', 'armGroupLabels': ['Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mia Minen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Langone Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Requests should be directed to Mia.Minen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}