NCT05466682

RELAXaHEAD for Headache Patients (Phase II)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Migraine
• Headache
• Multiple Sclerosis
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)	Relaxation technique delivered via RELAXaHEAD app.
BEHAVIORAL	Monitored Usual Care (MUC)	Standard of care plus daily symptom reporting using the RELAXaHEAD app electronic diary.

Timeline

• Start date: 2022-06-09
• Primary completion: 2022-12-19
• Completion: 2023-06-19
• First posted: 2022-07-20
• Last updated: 2024-01-10
• Results posted: 2024-01-10

Locations

1 site across 1 country: United States