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Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) for Migraine

N/A
Waitlist Available
Led By Mia Minen, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights

Summary

This trial is testing a smartphone app called RELAXaHEAD, which helps people with migraines and insomnia relax their muscles and track their headaches. The study aims to see if the app is easy to use and if it helps improve headache and sleep symptoms. The RELAXaHEAD app includes an electronic headache diary and progressive muscle relaxation (PMR) intervention, which has been previously adapted for smartphone applications for other conditions.

Eligible Conditions
  • Migraine
  • Headache
  • Multiple Sclerosis
  • Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Daily Diary Satisfaction Scores
Number of Days Participants Used Diary
Number of Days RELAX Arm Participants Performed Progressive Muscle Relaxation Therapy (PMR) at Least 5 Minutes/Day
+2 more
Secondary study objectives
Change in Headache (HA) Intensity Over Past 30 Days
Change in Number of Headache (HA) Days Over Past 30 Days
Minutes/Day of Progressive Muscle Relaxation Therapy (PMR) Use among RELAX Arm Participants
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RELAXExperimental Treatment1 Intervention
Patients will receive Progressive Muscle Relaxation Therapy (PMR) via the RELAXaHEAD smart-phone app. Patients will be asked to do the following: * Week 1: 5 min deep breathing at least 5/7 days of the week * Week 2: 5 min PMR session at least 5/7 days of the week * Week 3: 15 min PMR session at least 5/7 days of the week * Week 4: PMR at least 4 days a week * Week 5: PMR at least 3 days a week * Weeks 6-8: Use PMR when it is most helpful Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the app. They will also receive written educational material about migraine.
Group II: Monitored Usual Care (MUC)Active Control1 Intervention
Patients will be given a general education session consisting of basic migraine information. They will receive the RELAXaHEAD app but the Progressive Muscle Relaxation Therapy (PMR) function will be blocked. Patients will be asked to track headache frequency, intensity, sleep, and acute medication use on the RELAXaHEAD app. They will also receive written educational material about migraine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
2022
N/A
~50

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,794 Total Patients Enrolled
9 Trials studying Migraine
1,075 Patients Enrolled for Migraine
Center for Advancing Point of Care TechnologiesUNKNOWN
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,159 Total Patients Enrolled
~15 spots leftby Sep 2025
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