RELAXaHEAD for Headache Patients (Phase II)

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Headache
Insomnia
Migraine
Migraine Disorders
Multiple Sclerosis
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT05466682
Study type	Interventional
Source	NYU Langone Health
Contact
Status	Completed
Phase	N/A
Start date	June 9, 2022
Completion date	June 19, 2023

View Details

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