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NCT05466682 · ClinicalTrials.gov registry record · NA
RELAXaHEAD for Headache Patients (Phase II)
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
NCT05466682: Completed NA study, sponsored by NYU Langone Health.
NCT05466682 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 48 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05466682, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
Study 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).
Primary Outcome
Measure of feasibility.
Interventions
- BEHAVIORAL Monitored Usual Care (MUC)
- BEHAVIORAL Smartphone-Based Progressive Muscle Relaxation Therapy (PMR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2023-06-19 |
| Phase | NA |
What the finished NCT05466682 record still lists
NCT05466682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Monitored Usual Care (MUC) is the first listed.
NCT05466682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05466682 about?
NCT05466682 is a clinical study titled "RELAXaHEAD for Headache Patients (Phase II)". 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. ...
What is the current status of trial NCT05466682?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2022-06-09. Estimated completion is 2023-06-19.
What interventions are being tested in trial NCT05466682?
The interventions under investigation include: Monitored Usual Care (MUC) (BEHAVIORAL), Smartphone-Based Progressive Muscle Relaxation Therapy (PMR) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05466682?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05466682's enrollment target sits among peer trials
48 1381st of 2000 higher than 601 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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