Heartmath Migraine Study

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Behavioral: HeartMath; Behavioral: Waitlist Control

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 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Waitlist Control	Behavioral: 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.; Behavioral: Waitlist Control; Standard of Care Migraine Treatment
Experimental: HeartMath	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mia Minen, MD, MPH, New York Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2019
• Primary Completion (Actual): January 16, 2020
• Study Completion (Actual): January 16, 2020

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: HeartMath app; Inner Balance Sensor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 19-00479

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Requests should be directed to Mia.Minen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No