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NCT03183791 · ClinicalTrials.gov registry record · NA
RELAXaHEAD for Headache Patients (Phase I)
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 402
- Enrollment target
NCT03183791: Completed NA study, sponsored by NYU Langone Health.
NCT03183791 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 402 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03183791, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 402 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 headaches. 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. This 2-arm randomized controlled study will evaluate the feasibility and acceptability of RELAX for use with headache patients. 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 headache (Aim 1) and to gather exploratory data on the effects of the RELAX intervention on headache related outcome measures (Aim 2).
Primary Outcome
Measure of feasibility
Interventions
- BEHAVIORAL Monitored Usual Care (MUC)
- BEHAVIORAL RELAXaHEAD app
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2019-05-25 |
| Phase | NA |
What the finished NCT03183791 record still lists
NCT03183791 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Monitored Usual Care (MUC) is the first listed.
NCT03183791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03183791 about?
NCT03183791 is a clinical study titled "RELAXaHEAD for Headache Patients (Phase I)". The goal of this research is to assess the utility of smartphone-based progressive muscle relaxation (PMR) for the treatment of headaches. While there are many commercially available electronic diary and mind-body intervention apps for headache, there is little data showing their efficacy. RELAXaHEA...
What is the current status of trial NCT03183791?
This trial is currently completed. It is a NA study. The enrollment target is 402 participants. The study started on 2017-11-01. Estimated completion is 2019-05-25.
What interventions are being tested in trial NCT03183791?
The interventions under investigation include: Monitored Usual Care (MUC) (BEHAVIORAL), RELAXaHEAD app (BEHAVIORAL).
Who is sponsoring clinical trial NCT03183791?
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 NCT03183791's enrollment target sits among peer trials
402 245th of 2000 higher than 1,755 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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