App-based Breathing Program for Migraine Relief

NCT07297901 | Enrolling By Invitation

• 1 other identifier: STUDY00023014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

heart rate variability biofeedback; migraine; headache; chronic pain; remotely delivered

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline Migraine Frequency at 28 days

  Migraine frequency will be assessed by the change from baseline in monthly (28-day) migraine days or moderate/severe headache days, assessed by the end of day headache daily diary .

  One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)

Secondary Outcomes (6)

• Pain Catastrophizing Scale

  Baseline (T1) and 8 weeks after baseline (T3)

• Emotional Regulation Questionnaire

  Basline (T1) and 8 weeks after baseline (T3)

• Changes from 1-month after baseline (T2) Heart Rate Variability measurement at T3

  One month after baseline (T2), 8 weeks after baseline (4 weeks after T2) (T3)

• Depression Anxiety Stress Scale - Short Form (DASS-21)

  Baseline (T1) and 8 weeks after baseline (T3)

• Insomnia Severity Index (ISI)

  Baseline (T1) and 8 weeks after baseline (T3)

Study Arms (2)

Baseline and HRVB

EXPERIMENTAL

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.

Behavioral: Baseline Survey; Behavioral: Heart rate variability biofeedback

Baseline and Sham Control Group

SHAM COMPARATOR

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.

Behavioral: Baseline Survey; Behavioral: Sham Control Group

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.

Baseline and HRVB; Baseline and Sham Control Group

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.

Baseline and HRVB

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.

Baseline and Sham Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Any form of mind-body intervention (3 or more times per week) during the past 3 months.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Chronic Pain; Respiratory Aspiration

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 22, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)