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RELAXaHEAD for Headache Patients (Phase II): RELAXaHEAD for Migraine and Sleep
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).
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
NYU Langone Health
New York, New York, United States
Start Date
June 9, 2022
Primary Completion Date
December 19, 2022
Completion Date
June 19, 2023
Last Updated
January 10, 2024
48
ACTUAL participants
Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
BEHAVIORAL
Monitored Usual Care (MUC)
BEHAVIORAL
Lead Sponsor
NYU Langone Health
Collaborators
NCT07018713
NCT07225504
NCT06276634
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