RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Long COVID, Long COVID-19, Sleep Disturbance

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

NCT06404112

Run by

Duke University

People needed

469

Starts

2024-07-31

Expected to finish

2026-04-01

Last updated by the study team

2026-07-08

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
• 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
• Severe progressive retinal disease, eg, macular degeneration
• Permanently dilated pupil, eg, following certain cataract surgeries
• Unwilling to remove or not wear blue-light-blocking glasses during TL dosing
• MELATONIN EXCLUSION CRITERIA
• Sleep medication, if not willing to washout for 4 weeks.

Where it is running

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

Full record on ClinicalTrials.gov

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