The platform protocol is designed to be flexible so that it is suitable for a range ofstudy settings and intervention types. Therefore, the platform protocol provides ageneral protocol structure that can be shared by multiple interventions and allowscomparative analysis across the interventions. For example, objectives, measures, andendpoints are generalized in the platform protocol, but intervention-specific featuresare detailed in separate appendices.This platform protocol is a prospective, multi-center, multi-arm, randomized controlledplatform trial evaluating potential interventions for PASC-mediated sleep disturbances.The hypothesis is that symptoms of sleep and circadian disorders that emerge in patientswith PASC can be improved by phenotype-targeted interventions. Specific sleep andcircadian disorders addressed in this protocol include sleep-related daytime impairment(referred to as hypersomnia) and complex PASC-related sleep disturbance (reflectingsymptoms of insomnia and sleep-wake rhythm disturbance).
Interventions will be added to the platform protocol as appendices. Each appendix will
leverage all elements of the platform protocol, with additional elements described in the
individual appendix.
After completing Baseline assessments, participants will be randomized to an intervention
group, which is based on their sleep phenotype, or into a placebo/control group.
Drug: Melatonin
Melatonin dosing will be one tablet of 3 mg immediate release daily consumed 2 hours
before the participant's desired bedtime, which is defined as the time at which the
participant tries to fall asleep.
Drug: Melantonin Placebo
Melatonin placebo dosing will be one placebo tablet once daily consumed 2 hours before
the participant's desired bedtime.
Device: Tailored lighting (TL) Active
TL will be delivered similarly to both active and placebo groups, but the circadian
stimulus (the amount of light) will be different, albeit practically unidentifiable to
participants.
Device: Tailored lighting (TL) Placebo
TL will be delivered similarly to both active and placebo groups, but the circadian
stimulus (the amount of light) will be different, albeit practically unidentifiable to
participants.
Inclusion Criteria:
• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which
applies to this appendix
Exclusion Criteria:
• 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
1. Severe visual impairments affecting sensitivity or ability to respond to light
2. Severe photosensitivity dermatitis
3. Severe progressive retinal disease, eg, macular degeneration
4. Permanently dilated pupil, eg, following certain cataract surgeries
5. 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.
All sites listed under NCT06404086
Durham, North Carolina, United States
Jaelyn R Linski, BA, CCRC
919-668-8060
recoverresearch@duke.edu
Barrie L Harper, BSMT (ASCP) PMP
recoverresearch@duke.edu