Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2019-06-16
2020-01-16
Brief Summary
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Detailed Description
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* 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.
* 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.
* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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HeartMath
HeartMath
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.
Waitlist Control
HeartMath
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.
Waitlist Control
Standard of Care Migraine Treatment
Interventions
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HeartMath
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.
Waitlist Control
Standard of Care Migraine Treatment
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
MALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Mia Minen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
New York Langone Medical Center
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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19-00479
Identifier Type: -
Identifier Source: org_study_id
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