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NCT06404099 · ClinicalTrials.gov registry record · Phase 2
RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
A Phase 2 study of Long COVID and Long COVID-19, sponsored by Duke University.
- Active
- Registry status
- Phase 2
- Development phase
- 361
- Enrollment target
- 1
- Study location
NCT06404099: Active Phase 2 study of Long COVID and Long COVID-19, sponsored by Duke University.
NCT06404099 is a Phase 2 study of Long COVID and Long COVID-19 that is active but no longer recruiting, run by Duke University. The registered enrollment target is 361 participants, below the 2,181-participant average among 50 other Long COVID trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06404099, a Phase 2 study of Long COVID and Long COVID-19, is active but no longer recruiting, sponsored by Duke University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 361 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 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with 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 greater sleep-related impairment.
Conditions Studied
Interventions
- DRUG Modafinil
- DRUG Solriamfetol
- DRUG Modafinil Placebo
- DRUG Solriamfetol Placebo
Study Locations (1)
North Carolina
- All sites listed under NCT06404086 - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2024-08-12 |
| Est. Completion | 2026-04-15 |
| Phase | Phase 2 |
What the registry record for NCT06404099 still lists
NCT06404099 is an interventional study that assigns participants to a tested intervention. The registered 361 participants enrollment target is mid-sized for trials with a published cap, below the 2,181-participant average among 50 other Long COVID trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Long COVID appearing as the primary indexed condition, and to 4 interventions - of which Modafinil is the first listed.
NCT06404099 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06404099 about?
NCT06404099 is a clinical study titled "RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)". 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 NCT06404099?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 361 participants. The study started on 2024-08-12. Estimated completion is 2026-04-15.
What conditions does trial NCT06404099 study?
This clinical trial studies the following conditions: Long COVID, Long COVID-19, Hypersomnia.
What interventions are being tested in trial NCT06404099?
The interventions under investigation include: Modafinil (DRUG), Solriamfetol (DRUG), Modafinil Placebo (DRUG), Solriamfetol Placebo (DRUG).
Who is sponsoring clinical trial NCT06404099?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06404099 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
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Where NCT06404099's enrollment target sits among peer trials
361 8th of 50 higher than 43 of 50 other Long COVID trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Long COVID 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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