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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 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 402 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03183791
The ClinicalTrials.gov registry entry for NCT03183791 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 402 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Monitored Usual Care (MUC) is the first listed.
NCT03183791 reports 0 study locations.
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.
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