MigraineNCT07297901
App-based Breathing Program for Migraine Relief
A study testing Baseline Survey and Heart rate variability biofeedback in people with Migraine and Heart Rate Variability (HRV), run by Arizona State University at 1 site in United States.
Trial summary
Migraine is one of the most common neurological disorders, characterized by recurrent headaches, sensitivity to light and movement, nausea, and autonomic dysregulation. Although mind-body interventions like biofeedback have shown their efficacy, they remain underutilized due to barriers such as transportation, time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Heart Rate Variability (HRV), Autonomic Nervous System
- What is being tested?
- Baseline Survey and Heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 30 Sep 2026
- Phase
- Interventional
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years or older
- Chronic migraine as determined by the Identify Chronic Migraine (ID-CM) assessment
- Access to a smartphone and Wi-Fi
- Fluent in English.
Who cannot join
- Major medical (e.g., cancer, HIV/AIDS) or psychiatric illness (e.g., schizophrenia)
- Conditions that would potentially interfere with accurate detection of HRV data (i.e., medications that alter heart rhythms, indications of cardiac conduction abnormalities [e.g., heart arrhythmias], having a pacemaker or heart transplant)
- Any form of mind-body intervention (3 or more times per week) during the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Headache Calm: App-based Breathing Program for Migraine Relief
Migraine is one of the most common neurological disorders, characterized by recurrent headaches, sensitivity to light and movement, nausea, and autonomic dysregulation. Although mind-body interventions like biofeedback have shown their efficacy, they remain underutilized due to barriers such as transportation, time constraints, lack of awareness, stigma, and cost. A targeted approach to enhancing HRV is HRV biofeedback (HRVB), a technique using visual or auditory feedback to help people regulate HRV through slow-paced breathing and positive emotional regulation to promote ANS balance and emotional resilience. Investigators will conduct a remotely delivered pilot RCT of an 8-week, 10 min/day, novel app-based HRVB intervention compared to a sham control intervention (matching intervention time and attention with no biofeedback component) in adult with chronic migraine. Investigators hypothesize data collected from the study will: a) support the feasibility and acceptability of the remotely delivered app-based HRVB intervention among adults with chronic migraine, and b) provide insights into refining the intervention by examining patterns of change in migraine and psychological outcomes from pre- to post-intervention.
Read the detailed description
This study is a randomized controlled trial aimed at examining the effect of Heart Rate Variability Biofeedback (HRVB) among people with chronic migraine. The primary objective of the study is to determine whether HRVB can positively impact the psychosocial health and well-being of those living with chronic migraines. Building upon our prior pilot RCT (IRB study ID: STUDY00018977; ClinicalTrials.gov ID: NCT06546163), which demonstrated the feasibility and acceptability of HRVB in college-aged women with disordered eating, investigators propose to examine the feasibility of a HRVB intervention using the device investigators have successfully implemented remotely, incorporating video guides and Zoom-based coaching for smartphone app set-up and use. Investigators will conduct a remotely delivered pilot RCT of an 8-week, 10 min/day, novel app-based HRVB intervention compared to a sham control intervention (matching intervention time and attention with no biofeedback component) in adult with chronic migraines. There will be 30 participants who experience chronic migraines that will participate in the study and they will be randomly assigned to either the HRVB intervention group or the control group (15 for each group). Participants will first attend a baseline orientation meeting during which they complete baseline measures and will be asked to complete 28 days of a 5-10 minute daily diary survey about their migraine-related experiences. After the 28 days, participants will attend a zoom training meeting during which they complete a 5-minute heart rate measurement using a small earlobe sensor device that investigators will mail to participants , will be randomly assigned to the HRVB group or sham control group, and be asked to complete the daily diary assessments for another 28 days. After 8 weeks since the baseline and 4 weeks since group assignment, participants will attend a final zoom meeting to complete follow-up measures and the heart rate measurement. Investigators hypothesize data collected from the study will: a) support the feasibility and acceptability of the remotely delivered app-based HRVB intervention among adults with chronic migraines, and b) provide insights into refining the intervention by examining patterns of change in migraine and psychological outcomes from pre- to post-intervention.
- Conditions
- Migraine, Heart Rate Variability (HRV), Autonomic Nervous System, Headache (Migraine), Headache, Chronic Pain
- Being tested
- Baseline Survey, Heart rate variability biofeedback, Sham Control Group
- Keywords
- heart rate variability biofeedback, migraine, headache, chronic pain, remotely delivered
- Medical subject headings
- Migraine Disorders, Headache, Chronic Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline SurveyBehavioural
Baseline surveys contain a series of scaled questions, including sociodemographic variables (age, sex, etc), information about migraine frequency and intensity, Insomnia Severity Index (ISI), Grade Chronic Pain Scale Revised (GCPS-R), Pain Catastrophizing Scale (PCS), Emotional Regulation Questionnaire (ERQ), Depression Anxiety Stress Scale-21 (DASS-21), and treatment expectations.
Heart rate variability biofeedbackBehavioural
Participants randomized to the intervention arm will receive a standardized HRV sensor and accompanying smartphone application, along with a 30-40-minute HRVB training session focused on using biofeedback signals to generate a resonant frequency pattern of HRV (coherence) following baseline data collection. Participants will be asked to practice their HRVB skills at home for 10 minutes per day over a 8-week period.
Sham Control GroupBehavioural
Participants randomized to the sham control arm will receive a standardized HRV sensor and accompanying smartphone application, along with a 30-40-minute sham breathing training session following baseline data collection. Participants will be asked to practice their sham breathing exercises at home for 10 minutes per day over an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| Baseline and HRVB | Experimental | Participants will complete an online baseline survey and 28 days of baseline daily headache diary assessments prior to random assignment to the HRVB arm. This group will receive a standardized HeartMath© Inner Balance device by mail. Participants will attend a 30-40-minute one-on-one HRVB training session via Zoom prior to initiating the HRVB intervention and will be asked to practice HRV biofeedback at home for 10 minutes per day over an eight-week period.
Participants will receive an email or phone notification as a weekly reminder to complete their at-home HRVB practice. At the end of the 8-week intervention period, participants will be scheduled for a follow-up Zoom meeting to collect a 5-minute post-intervention resting HRV measurement and will complete the T2 online survey. Receives: Behavioral: Baseline Survey; Behavioral: Heart rate variability biofeedback |
| Baseline and Sham Control Group | Sham comparator | Participants will complete an online baseline survey and 28 days of baseline daily headache diary assessments prior to randomization to the sham control arm. Participants will receive a standardized HeartMath© Inner Balance device by mail and will attend a 30-40-minute one-on-one sham training session via Zoom before initiating the sham intervention. They will be instructed to engage in normal breathing at home for 10 minutes per day over an eight-week period, without receiving HRV biofeedback or real-time visualization. Weekly email or phone reminders will be provided to support adherence. At the end of the 8-week intervention period, participants will attend a follow-up Zoom visit to complete a 5-minute post-intervention resting HRV measurement and the T2 online survey. Receives: Behavioral: Baseline Survey; Behavioral: Sham Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Migraine Frequency at 28 days
Migraine frequency will be assessed by the change from baseline in monthly (28-day) migraine days or moderate/severe headache days, assessed by the end of day headache daily diary .
Measured: One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)
Secondary outcomes (6)
Pain Catastrophizing Scale
An individual's pain experience will be measured using the Pain Catastrophizing Scale (PCS) (13 items, 5-point Likert scale; 0=not at all, 4= all the time ). The PCS has three subscales: rumination, magnification, and helplessness. The PCS has been used and validated in studies of psychosocial interventions for migraine patients. Individual scores on the PCS can range from 0 to 52 with higher scores indicating a worse pain experience . (Cronbach's a = .87).
Measured: Baseline (T1) and 8 weeks after baseline (T3)
Emotional Regulation Questionnaire
Emotional regulation strategies will be measured using the Pain Catastrophizing Scale (ERQ) (10 items, 7-point Likert scale; 1= strongly disagree, 7= strongly agree). The ERQ has two subscales: cognitive reappraisal and expressive suppression. The ERQ has been used and validated in studies of psychosocial interventions for migraine patients. Individual scores on the PCS can range from 10 to 70 with higher scores indicating a greater frequency of use of emotional regulation strategies (Cronbach's a = 0.76-0.83).
Measured: Basline (T1) and 8 weeks after baseline (T3)
Changes from 1-month after baseline (T2) Heart Rate Variability measurement at T3
The InnerBalance from HeartMath will be used to collect HRV data using a 5-minutes "neutral" protocol (we call "waiting at the bus stop" implying that no particular intent for breath or mindful state is to be evoked) to understand the benefits of HRVB. In addition, HRV measures will be obtained for the 10-minute paced breathing period per day to understand the effects of paced breathing on migraine during the intervention period. The following precautions will be provided as instructions to participants prior to data collection: no coffee, tea, or caffeinated drinks such as energizing drinks in the 2 hours before the data collection, and no alcohol consumption during 24 hours prior to the data collection.
Measured: One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)
Depression Anxiety Stress Scale - Short Form (DASS-21)
General psychological distress will be measured using the Depression Anxiety Stress Scale (DASS-21) (21 items, 4-point Likert scale; 0= Did not apply to me at all, 3= Applied to me very much). The ERQ has three subscales: depression, anxiety, and stress. The ERQ has been used and validated in studies of psychosocial interventions for migraine patients. Individual scores on the DASS-21 can range from 0 to 63 with higher scores indicating greater levels of general psychological distress (Cronbach's a = 0.74).
Measured: Baseline (T1) and 8 weeks after baseline (T3)
Insomnia Severity Index (ISI)
Severity of insomnia will be measured using the Insomnia Severity Index (ISI) (7 items, 5-point Likert scale; 0=None, 4=Very severe). The ISI has been used and validated in studies of psychosocial interventions for migraine patients. Individual scores on the DASS-21 can range from 0 to 28 with higher scores indicating more sever insomnia (Cronbach's a = 0.74).
Measured: Baseline (T1) and 8 weeks after baseline (T3)
Graded Chronic Pain Scale-Revised (GCPS-R)
Chronic pain severity will be measured using the Graded Chronic Pain Scale-Revised (GCPS-R) (5 items, 5-point Likert scale; 0 = Not at all, 4 = Extremely). The GCPS-R is one of the most frequently used and validated scales in studies of psychosocial interventions for migraine patients.The scores on the GCPS-R can can be classfied form Grade 0 (no chronic pain) to Grade 3 (high impact chronic pain) (Cronbach's a = 0.87-0.94).
Measured: Baseline (T1) and 8 weeks after baseline (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start15 Dec 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunny Wonsun Kim, Ph.D, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297901
- Sponsor's protocol ID
- STUDY00023014
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No