CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05466682
NCT05466682N/ACompleted

RELAXaHEAD for Headache Patients (Phase II): RELAXaHEAD for Migraine and Sleep

NYU Langone Health·interventional·Posted Jul 20, 2022·Updated Jan 10, 2024

In Brief

A clinical study evaluating Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) and Monitored Usual Care (MUC) for Migraine and 3 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of migraine and sleep. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEAD app incorporates the electronic PMR that was successfully used in an earlier epilepsy study and beta tested with headache specialist and migraine patient input. It also is an electric headache diary. The app has been studied and findings have been reported in multiple peer reviewed publications. Also, the app has been updated based on prior feedback from the studies. Now, this 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAXaHEAD for use with patients with migraine and comorbid insomnia. . One arm will be the RELAX group (the RELAXaHEAD app) and the other arm will be a monitored usual care (MUC) group (this group receives standard of care and uses the electronic daily symptom reporting diary). The goals are to assess the feasibility and adherence of the RELAX intervention in persons with migraine and insomnia (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache and sleep related outcome measures (Aim 2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 20, 2022
Enrollment StartJun 9, 2022
Primary CompletionDec 19, 2022
Study CompletionJun 19, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.9 years ago

Interventions

Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)behavioral

Relaxation technique delivered via RELAXaHEAD app.

Monitored Usual Care (MUC)behavioral

Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.