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NCT06404112 · ClinicalTrials.gov registry record · Phase 2
RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)
A Phase 2 study of Sleep Disturbance and Long COVID, sponsored by Duke University.
- Active
- Registry status
- Phase 2
- Development phase
- 470
- Enrollment target
- 1
- Study location
NCT06404112: Active Phase 2 study of Sleep Disturbance and Long COVID, sponsored by Duke University.
NCT06404112 is a Phase 2 study of Sleep Disturbance and Long COVID that is active but no longer recruiting, run by Duke University. The registered enrollment target is 470 participants, above the 169-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (178% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06404112, a Phase 2 study of Sleep Disturbance and Long COVID, is active but no longer recruiting, sponsored by Duke University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 470 participants
- Enrollment target
- 1
- Study location
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
The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance.
Conditions Studied
Interventions
- DRUG Melatonin
- DRUG Melantonin Placebo
- DEVICE Tailored lighting (TL) Active
- DEVICE Tailored lighting (TL) Placebo
Study Locations (1)
North Carolina
- All sites listed under NCT06404086 - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 470 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2026-04-03 |
| Phase | Phase 2 |
What the registry record for NCT06404112 still lists
NCT06404112 is an interventional study that assigns participants to a tested intervention. The registered 470 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (178% higher).
The record links to 3 conditions, with Sleep Disturbance appearing as the primary indexed condition, and to 4 interventions - of which Melatonin is the first listed.
NCT06404112 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06404112 about?
NCT06404112 is a clinical study titled "RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)". 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 NCT06404112?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 470 participants. The study started on 2024-07-31. Estimated completion is 2026-04-03.
What conditions does trial NCT06404112 study?
This clinical trial studies the following conditions: Sleep Disturbance, Long COVID, Long COVID-19.
What interventions are being tested in trial NCT06404112?
The interventions under investigation include: Melatonin (DRUG), Melantonin Placebo (DRUG), Tailored lighting (TL) Active (DEVICE), Tailored lighting (TL) Placebo (DEVICE).
Who is sponsoring clinical trial NCT06404112?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06404112 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Disturbance
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 NCT06404112's enrollment target sits among peer trials
470 4th of 56 higher than 53 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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