NCT06404112CompletedPhase 2
RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)
RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 469 (actual)
- First submitted
- 6 May 2024
- Start date
- 31 Jul 2024
- Primary completion date
- 26 Feb 2026
- Lead sponsor
- Duke University
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06404112
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 469
- From 31 Jul 2024 to the primary completion date, 26 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unwilling to remove or not wear blue-light-blocking glasses during TL dosing
- MELATONIN EXCLUSION CRITERIA
- 1\. Sleep medication, if not willing to washout for 4 weeks.
Other illness
- Severe progressive retinal disease, eg, macular degeneration
Other
- See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix
- Additional Appendix B (CPSD) Level Inclusion Criteria:
- The following additional exclusion criteria are to be considered together for determining eligibility. They are separated here by TL and melatonin only for presentation. RESET-PASC presents no additional exclusions.
- TAILORED LIGHTING EXCLUSION CRITERIA
- Severe visual impairments affecting sensitivity or ability to respond to light
- Severe photosensitivity dermatitis
- Permanently dilated pupil, eg, following certain cataract surgeries
Who the study is looking for
- See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All sites listed under NCT06404086 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.