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App-based Breathing Program for Migraine Relief
Sponsor: Arizona State University
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 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.
Official title: Headache Calm: App-based Breathing Program for Migraine Relief
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-12-15
Completion Date
2026-05-30
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
Baseline Survey
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 biofeedback
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 Group
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.
Locations (1)
Arizona State University
Phoenix, Arizona, United States