Heartmath Migraine Study

NYU Langone Health

Status

Completed

Conditions

Migraine

Treatments

Behavioral: Waitlist Control

Behavioral: HeartMath

Study type

Interventional

Funder types

Other

Identifiers

NCT04077658

19-00479

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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