RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)

PHASE2RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Long COVIDLong COVID-19Sleep Disturbance
Interventions
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.

Trial Locations (1)

27710

RECRUITING

All sites listed under NCT06404086, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT06404112 - RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD) | Biotech Hunter | Biotech Hunter