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.

NCT Number	NCT07297901
Lead Sponsor	Arizona State University
Conditions	Migraine, Heart Rate Variability (HRV), Autonomic Nervous System, Headache (Migraine), Headache, Chronic Pain, mHealth, Breathing
Enrollment	30 participants
Start Date	2025-12-15
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-23