NCT07297901Enrolling by invitation
App-based Breathing Program for Migraine Relief
Headache Calm: App-based Breathing Program for Migraine Relief
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Dec 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Arizona State University
- Diseases
- Migraine
- NCT number
- NCT07297901
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Dec 2025 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Any form of mind-body intervention (3 or more times per week) during the past 3 months.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arizona State University Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.