App-based Breathing Program for Migraine Relief
Enrolling by invitationNot applicableNCT07297901
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Headache Calm: App-based Breathing Program for Migraine Relief
- Conditions
- Migraine
- Heart Rate Variability (HRV)
- Autonomic Nervous System
- Headache (Migraine)
- Headache
- Chronic Pain
- mHealth
- Breathing
- Interventions
- Behavioral: Baseline Survey
- Behavioral: Heart rate variability biofeedback
- Behavioral: Sham Control Group
- Sponsor
- Arizona State University
- Start date
- 2025-12-15
- Primary completion
- 2026-09-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Individuals aged 18 years or older 2. Chronic migraine as determined by the Identify Chronic Migraine (ID-CM) assessment 3. Access to a smartphone and Wi-Fi 4. Fluent in English. Exclusion Criteria: 1. Major medical (e.g., cancer, HIV/AIDS) or psychiatric illness (e.g., schizophrenia) 2. 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) 3. Any form of mind-body intervention (3 or more times per week) during the past 3 months.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07297901