RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

Completed · Phase 2 · Has a placebo group

Conditions studied: Long COVID, Long COVID-19, Hypersomnia

In brief

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).

Key facts

Study ID: NCT06404099
Run by: Duke University
People needed: 361
Starts: 2024-08-12
Expected to finish: 2026-04-20
Last updated by the study team: 2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix

You may not qualify if…

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
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)*
Known estimated glomerular filtration rate <30 mL/min/1.73 m2 and/or chronic dialysis*
Recent myocardial infarction (<1 year), unstable angina, serious cardiac arrhythmias, or other serious heart problems, at the discretion of the investigator
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.
Known severe left ventricular hypertrophy, mitral valve prolapse
SOLRIAMFETOL EXCLUSION CRITERIA
Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days
Current use of dopaminergic drugs

Where it is running

All sites listed under NCT06404086 — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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