Heartmath Migraine Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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.

Official Title
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A Pilot Single-center Randomized Controlled Study of the Effects of Smartphone Based Heart Rate Variability Biofeedback in People With Migraine

Conditions
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Migraine

Intervention / Treatment
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* Behavioral: HeartMath
* Behavioral: Waitlist Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Doing any form of behavioral therapy for pain in the past year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with intervention arm and waitlist control arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartMath<br> | Behavioral: HeartMath<br>* 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.<br>|
| Active Comparator: Waitlist Control<br> | Behavioral: HeartMath<br>* 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.<br>Behavioral: Waitlist Control<br>* Standard of Care Migraine Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HeartMath app, Inner Balance Sensor