App-based Breathing Program for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new app-based breathing program designed to help individuals with chronic migraines. The goal is to determine if this program can improve migraines using HRV biofeedback, a technique that balances the nervous system through controlled breathing and emotional regulation. Participants will be divided into two groups: one using the HRV biofeedback app and the other performing regular breathing exercises without feedback. The study seeks adults with chronic migraines who have a smartphone and Wi-Fi. As an unphased trial, it offers a unique opportunity to explore innovative migraine relief methods through technology.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on medications that alter heart rhythms, you may not be eligible to participate.
What prior data suggests that this app-based breathing program is safe for migraine patients?
Research shows that an app for heart rate variability biofeedback (HRVB) is generally well-received by people with migraines. Studies have found this treatment easy to use and acceptable for short periods. Although major improvements in main health outcomes have not been observed, no serious side effects have been linked to the app, suggesting it is safe for most people. Participants practice slow breathing and emotion management, which helps balance the body's automatic functions and boosts emotional strength. Overall, the treatment appears safe and comfortable to use.12345
Why are researchers excited about this trial?
Researchers are excited about the app-based breathing program for migraines because it offers a novel, non-drug approach to managing the condition. Unlike standard treatments that often rely on medications to alleviate migraine symptoms, this program uses heart rate variability biofeedback (HRVB) delivered through an app, allowing participants to actively engage in their treatment from home. This technique not only provides an innovative delivery method but also empowers users to potentially improve their migraine symptoms through daily practice. Additionally, the focus on HRVB may help reduce stress and enhance overall well-being, offering a holistic benefit that traditional migraine medications don't typically address.
What evidence suggests that this app-based breathing program is effective for migraines?
Studies have shown that biofeedback can effectively reduce the frequency and severity of headaches in people with migraines. In this trial, participants in the HRVB arm will use heart rate variability biofeedback (HRVB) to manage their heart rate through slow breathing and positive thinking. This practice can help balance the nervous system and improve stress management. Users of app-based HRVB found it easy to use and acceptable, though it didn't always result in significant changes in migraine symptoms. This technique is promising as it provides a non-drug option for managing migraines, making it more affordable and convenient. While more research is needed, HRVB offers a hopeful method for those seeking to manage migraines without medication.12356
Are You a Good Fit for This Trial?
This trial is for adults with chronic migraines who are interested in trying an app-based breathing program. Participants should be able to commit to an 8-week program and have access to a device compatible with the app. Details on specific inclusion or exclusion criteria were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete an online baseline survey and 28 days of baseline daily headache diary assessments
Treatment
Participants engage in HRV biofeedback or sham control intervention for 10 minutes per day over an eight-week period
Follow-up
Participants attend a follow-up Zoom meeting to complete post-intervention measures and heart rate measurement
What Are the Treatments Tested in This Trial?
Interventions
- App-based Breathing Program
Trial Overview
The study tests a novel app that guides users through heart rate variability biofeedback (HRVB) exercises for migraine relief, comparing it against a sham control group without biofeedback. It's designed as an 8-week remote pilot randomized controlled trial requiring daily 10-minute sessions.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arizona State University
Lead Sponsor
Citations
Heartrate Variability Biofeedback for Migraine Using a ...
App-based HRV biofeedback was feasible and acceptable on a time-limited basis for people with migraine. Changes in the primary clinical outcome did not differ ...
App-based Breathing Program for Migraine Relief
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 ...
Efficacy of biofeedback for migraine: A systematic review ...
This meta-analysis confirms that biofeedback is an effective non-pharmacological intervention for reducing headache frequency and severity in migraines.
Study Details | NCT04077658 | Heartmath Migraine Study
The primary objective of this study is to determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) ...
5.
researchgate.net
researchgate.net/publication/348344469_Heartrate_variability_biofeedback_for_migraine_using_a_smartphone_application_and_sensor_A_randomized_controlled_trialHeartrate variability biofeedback for migraine using a ...
A randomized controlled trial evaluating an app-based HRV biofeedback therapy in patients with migraines did not show any changes in the primary outcome: ...
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