NCT04077658

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2020

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

August 19, 2019

Last Update Submit

August 21, 2020

Conditions

Migraine

Keywords

HeartMath appInner Balance Sensor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in depression

    8 Weeks

  • Change in anxiety

    8 Weeks

  • Change insomnia

    8 Weeks

Study Arms (2)

HeartMath

EXPERIMENTAL
Behavioral: HeartMath

Waitlist Control

ACTIVE COMPARATOR
Behavioral: HeartMathBehavioral: Waitlist Control

Interventions

HeartMathBEHAVIORAL

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.

HeartMathWaitlist Control
Waitlist ControlBEHAVIORAL

Standard of Care Migraine Treatment

Waitlist Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • International Classification of Headache Disorders (ICHD) 3 criteria for migraine
  • 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.

You may not qualify if:

  • Doing any form of behavioral therapy for pain in the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mia Minen, MD, MPH

    New York Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with intervention arm and waitlist control arm
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

September 4, 2019

Study Start

June 16, 2019

Primary Completion

January 16, 2020

Study Completion

January 16, 2020

Last Updated

August 24, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, ICF
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.
Access Criteria
Requests should be directed to Mia.Minen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)