Heartmath Migraine Study

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077658
• Other study ID #: 19-00479
• Status: Completed
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: January 16, 2020

Study information

• Verified date: August 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.
• Waitlist Control
Standard of Care Migraine Treatment

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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