Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 48 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05466682
The ClinicalTrials.gov registry entry for NCT05466682 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 48 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.
NCT05466682 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.