NCT06404099CompletedPhase 2
RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
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 3 Jun 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
- 361 (actual)
- First submitted
- 6 May 2024
- Start date
- 12 Aug 2024
- Primary completion date
- 24 Mar 2026
- Lead sponsor
- Duke University
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06404099
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 361
- From 12 Aug 2024 to the primary completion date, 24 Mar 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
- Current use of stimulant or wake-promoting medications, unless a washout is permitted
- Regular use of prescribed hypnotics for sleep (≥3 times per week); washout period is permitted.
- characterized by the screening labs: coagulation panel and CMP w/LFTs
- MODAFINIL EXCLUSION CRITERIA
- Modafinil can affect drug metabolism given its effect on enzymes such as CYP3A4 and CYP2C19. To assess for drug interactions, investigators should use the Lexicomp Drug Interactions System that is available at most institutions.
- o If the search yields "D" - Consider Modifying Therapy or "X" - Avoid Combination, then the ACTION is to exclude the potential participant.
- An important example of this is steroid hormonal contraceptives.
- If the search yields "C" - Monitor Therapy, then discuss with site PIs on a case-by-case basis.
- If the search yields "A" - No Known Interaction or "B" - No Action Needed, then proceed to screen/include the potential participant.
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days
- Current use of dopaminergic drugs
Other illness
- Poorly controlled hypertension (systolic blood pressure ≥140 or diastolic blood pressure ≥90 mmHg)
- Moderate to severe hepatic impairment (ie, Child-Pugh class B or C)\*
- Recent myocardial infarction (\<1 year), unstable angina, serious cardiac arrhythmias, or other serious heart problems, at the discretion of the investigator
Other
- See NCT06404086 for RECOVER-SLEEP: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study)
- Additional Appendix A (Hypersomnia) Level Exclusion Criteria:
- Self-reported sleep duration \<6 hours per night
- Known estimated glomerular filtration rate \<30 mL/min/1.73 m2 and/or chronic dialysis\*
- Known severe left ventricular hypertrophy, mitral valve prolapse
- SOLRIAMFETOL EXCLUSION CRITERIA
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.