App-based Breathing Program for Migraine Relief

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Arizona State University
Study ID
NCT07297901
Status
Enrolling By Invitation

Conditions

  • Autonomic Nervous System
  • Breathing
  • Chronic Pain
  • Headache
  • Headache (Migraine)
  • Heart Rate Variability (HRV)
  • Migraine
  • mHealth

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baseline Survey — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
May 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Baseline and HRVB
    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.
  • Sham Comparator: Baseline and Sham Control Group
    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.

Primary Outcome Measure

Changes from Baseline Migraine Frequency at 28 days [ Time Frame: One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Arizona State UniversityPhoenixArizona85004-

Find similar trials in Phoenix, AZ

By condition
Migraine
By specialty
Neurology
By research site
Arizona State University· Phoenix, AZ

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