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RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)
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).
Conditions:
🦠 Long COVID 🦠 Long COVID-19 🦠 Sleep Disturbance
🗓️ Study Start (Actual) 7 July 2024
🗓️ Primary Completion (Estimated) October 2025
✅ Study Completion (Estimated) October 2025
👥 Enrollment (Estimated) 600
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 May 2024
  • First Submitted that Met QC Criteria 6 May 2024
  • First Posted 8 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified June 2024
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