MigraineNCT04077658
Heartmath Migraine Study
A study testing HeartMath in people with Migraine, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Migraine
- What is being tested?
- HeartMath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2019to 16 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Doing any form of behavioral therapy for pain in the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- HeartMath, Waitlist Control
- Keywords
- HeartMath app, Inner Balance Sensor
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMathBehavioural
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 ControlBehavioural
Standard of Care Migraine Treatment
| Study group | Role | What they receive |
|---|---|---|
| HeartMath | Experimental | Not described Receives: Behavioral: HeartMath |
| Waitlist Control | Active comparator | Not described Receives: Behavioral: HeartMath; Behavioral: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 Weeks
Secondary outcomes (3)
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
Measured: 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.
Measured: 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).
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start16 Jun 2019
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with intervention arm and waitlist control arm
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mia Minen, MD, MPH, Principal investigator, New York Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077658
- Sponsor's protocol ID
- 19-00479
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2019
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single-center Randomized Controlled Study of the Effects of Smartphone Based Heart Rate Variability Biofeedback in People With Migraine
- ClinicalTrials.gov ID
- NCT04077658
- Acronym / sponsor ID
- 19-00479
- Conditions
- Migraine
- Keywords
- HeartMath app, Inner Balance Sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Jun 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with intervention arm and waitlist control arm
| Arm | Type | Receives |
|---|---|---|
| HeartMath | Experimental | Behavioral: HeartMath |
| Waitlist Control | Active comparator | Behavioral: HeartMath, Behavioral: Waitlist Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Doing any form of behavioral therapy for pain in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartMathHeartMath 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. | Behavioural | HeartMath, Waitlist Control |
| Waitlist ControlStandard of Care Migraine Treatment | Behavioural | Waitlist Control |
Primary outcome
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
Time frame: 8 Weeks
Measured by comparing the slope of reduction in MSQv2 scores
3 secondary outcomes
Change in depression
Time frame: 8 Weeks
Change in anxiety
Time frame: 8 Weeks
Change insomnia
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mia Minen, MD, MPH principal investigator
New York Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartMath in people with Migraine, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.