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NCT06404086 · ClinicalTrials.gov registry record · Phase 2
RECOVER-SLEEP: Platform Protocol
A Phase 2 study of Sleep Disturbance and Long COVID, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 830
- Enrollment target
- 20
- Study locations
NCT06404086: Completed Phase 2 study of Sleep Disturbance and Long COVID, sponsored by Duke University.
NCT06404086 is a Phase 2 study of Sleep Disturbance and Long COVID that has completed, run by Duke University. The registered enrollment target is 830 participants, above the 163-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (409% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06404086, a Phase 2 study of Sleep Disturbance and Long COVID, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 830 participants
- Enrollment target
- 20
- Study locations
Study Summary
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance).
Primary Outcome
Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT#.
Conditions Studied
Interventions
- DRUG Melatonin
- DRUG Modafinil
- DRUG Solriamfetol
- DRUG Modafinil Placebo
- DRUG Solriamfetol Placebo
Study Locations (20)
Georgia
- Grady Memorial Hospital - Atlanta
- Morehouse School of Medicine - Atlanta
- Emory University - Atlanta
- Atlanta VA Medical Center - Decatur
- Emory Hope Clinic - Decatur
Illinois
- Northwestern Memorial Hospital - Chicago
- Cook County Health Specialty Care Center - Chicago
- Rush University Medical Center - Chicago
- University of Illinois at Chicago - Chicago
- NorthShore Medical Group - Evanston
Arizona
- Banner University Medical Center Phoenix - Phoenix
- University of Arizona Banner Medical Center - Tucson
- The Southern Arizona VA Health Care System - Tucson
California
- Stanford University - Palo Alto
- University of California San Francisco General Hospital - San Francisco
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
- Denver Health and Hospital Authority - Denver
Florida
- University of Florida College of Medicine Jacksonville - Jacksonville
- Lakeland Regional Medical Center - Lakeland
District of Columbia
- Howard University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 830 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the finished NCT06404086 record still lists
NCT06404086 is an interventional study that assigns participants to a tested intervention. The registered 830 participants enrollment target is mid-sized for trials with a published cap, above the 163-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (409% higher).
The record links to 4 conditions, with Sleep Disturbance appearing as the primary indexed condition, and to 5 interventions - of which Melatonin is the first listed.
NCT06404086 names 20 study sites across 7 states, led by Georgia, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT06404086 about?
NCT06404086 is a clinical study titled "RECOVER-SLEEP: Platform Protocol". The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. ...
What is the current status of trial NCT06404086?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 830 participants. The study started on 2024-07-31. Estimated completion is 2025-12-31.
What conditions does trial NCT06404086 study?
This clinical trial studies the following conditions: Sleep Disturbance, Long COVID, Long COVID-19, Hypersomnia.
What interventions are being tested in trial NCT06404086?
The interventions under investigation include: Melatonin (DRUG), Modafinil (DRUG), Solriamfetol (DRUG), Modafinil Placebo (DRUG), Solriamfetol Placebo (DRUG).
Who is sponsoring clinical trial NCT06404086?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06404086 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06404086's enrollment target sits among peer trials
830 2nd of 56 the highest of 56 other Sleep Disturbance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Disturbance 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.
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