RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 469
- Locations
- 1
- Primary Endpoint
- Change in total score of the PROMIS 8b SD to assess sleep disturbance
Study Overview
Brief 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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Double blind
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •1. Sleep medication, if not willing to washout for 4 weeks.
Arms & Interventions
Active TL + Placebo Melatonin
The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.
Intervention: Tailored lighting (TL) Active (Device)
Placebo TL + Oral Melatonin
The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.
Intervention: Tailored lighting (TL) Placebo (Device)
Active TL + Oral Melatonin
The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.
Intervention: Tailored lighting (TL) Active (Device)
Active TL + Placebo Melatonin
The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.
Intervention: Melantonin Placebo (Drug)
Placebo TL + Placebo Melatonin
The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.
Intervention: Melantonin Placebo (Drug)
Placebo TL + Placebo Melatonin
The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.
Intervention: Tailored lighting (TL) Placebo (Device)
Active TL + Oral Melatonin
The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.
Intervention: Melatonin (Drug)
Placebo TL + Oral Melatonin
The Complex PASC-Related Sleep Disturbances (CPSD) Appendix B combines brief education and a tailored sleep timing prescription for CPSD (referred to as RESET-PASC) with therapies that modify circadian timing for participants who report poor sleep quality. The intervention therapies involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to one of four groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive RESET-PASC. The intervention duration will be 8 weeks.
Intervention: Melatonin (Drug)
Outcomes
Primary Outcomes
Change in total score of the PROMIS 8b SD to assess sleep disturbance
Time Frame: Baseline, End of Intervention (Day 63)
The PROMIS 8b SD form includes a total of 8 items that ask participants to reflect on their sleep over the past 7 days with one question rated very poor to very good and the remaining questions rated not at all to very much. T-Scores range from 0 to 100, with a score of 55 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance.
Change in sleep onset variability, assessed using a wearable device
Time Frame: Baseline, End of Intervention (Day 63)
A wearable device will be used as an objective measure to assess sleep onset variability assessed for 7 days before randomization and 7 days before EOI
Secondary Outcomes
- Change in PROMIS 10a Fatigue score(Baseline, End of Intervention (Day 63))
- Change in an objective neurocognitive battery score(Baseline, End of Intervention (Day 63))
- Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker(Baseline, End of Intervention (Day 63))
- Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker(Baseline, End of Intervention (Day 63))
- Change in total score of the PROMIS 8a SRI to assess sleep-related impairment(Baseline, End of Intervention (Day 63))
- Change in ECog2 measure(Baseline, End of Intervention (Day 63))
- Change in PASC Symptom Questionnaire responses(Baseline, End of Intervention (Day 63))
- Change in total score from ISI (Insomnia Severity Index)(Baseline, End of Intervention (Day 63))
- Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary(Baseline, End of Intervention (Day 63))
- Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary(Baseline, End of Intervention (Day 63))
- Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary(Baseline, End of Intervention (Day 63))
- Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary(Baseline, End of Intervention (Day 63))
- Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker(Baseline, End of Intervention (Day 63))
- Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker(Baseline, End of Intervention (Day 63))