RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)

Last updated: April 18, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Disorders

Narcolepsy

Insomnia

Treatment

Melantonin Placebo

Melatonin

Tailored lighting (TL) Active

Clinical Study ID

NCT06404112
Pro00112484_B
OTA-21-015G
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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.

Study Design

Total Participants: 600
Treatment Group(s): 4
Primary Treatment: Melantonin Placebo
Phase: 2
Study Start date:
July 31, 2024
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • All sites listed under NCT06404086

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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