Status:
COMPLETED
Heartmath Migraine Study
Lead Sponsor:
NYU Langone Health
Conditions:
Migraine
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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 qualit...
Eligibility Criteria
Inclusion
- International Classification of Headache Disorders (ICHD) 3 criteria for migraine
- 4-20 headache days/month
- Has not done behavioral therapy for migraine in the past year
- Has a smartphone and willing to try HRV biofeedback using an app and ear monitor
- English speaking
- HS graduate or higher level of education
- 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.
Exclusion
- Doing any form of behavioral therapy for pain in the past year
Key Trial Info
Start Date :
June 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04077658
Start Date
June 16 2019
End Date
January 16 2020
Last Update
August 24 2020
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016