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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartMath | Experimental |
| |
| Waitlist Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartMath | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Measured by comparing the slope of reduction in MSQv2 scores | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression | 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 | 8 Weeks |
| Change in anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mia Minen, MD, MPH | New York Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Requests should be directed to Mia.Minen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Randomized controlled trial with intervention arm and waitlist control arm
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| Waitlist Control | Behavioral | Standard of Care Migraine Treatment |
|
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.
| 8 Weeks |
| Change insomnia | 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). | 8 Weeks |
| D009422 | Nervous System Diseases |