RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)
- Conditions
- Long COVIDLong COVID-19Sleep Disturbance
- Interventions
- Drug: Melantonin PlaceboDevice: Tailored lighting (TL) ActiveDevice: Tailored lighting (TL) Placebo
- Registration Number
- NCT06404112
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
• See NCT06404086 for RECOVER-SLEEP: Platform Protocol level inclusion criteria which applies to this appendix
• 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
- Sleep medication, if not willing to washout for 4 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active TL + Placebo Melatonin Tailored lighting (TL) Active 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. Placebo TL + Oral Melatonin Tailored lighting (TL) Placebo 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. Active TL + Oral Melatonin Tailored lighting (TL) Active 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. Active TL + Placebo Melatonin Melantonin Placebo 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. Placebo TL + Placebo Melatonin Melantonin Placebo 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. Placebo TL + Placebo Melatonin Tailored lighting (TL) Placebo 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. Active TL + Oral Melatonin 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. Placebo TL + Oral Melatonin 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.
- Primary Outcome Measures
Name Time Method Change in total score of the PROMIS 8b SD to assess sleep disturbance 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 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 Outcome Measures
Name Time Method Change in PROMIS 10a Fatigue score Baseline, End of Intervention (Day 63) The PROMIS 10a Fatigue is a 10-item questionnaire that assesses a participant's fatigue on a scale of 1 (not at all fatigued) to 5 (very much).
Change in an objective neurocognitive battery score 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) The PROMIS 8a SRI form includes a total of 8 items that ask participants to reflect on their sleep-related daytime impairment over the past 7 days with questions rated not at all to very much. T-Scores range from 0 to 100, with \> 55 1 SD above population mean.
Change in ECog2 measure Baseline, End of Intervention (Day 63) Everyday Cognition 2 (ECog2) is a self-report, 41-item questionnaire used to measure measure the participant's perceived capacity to perform activities related to cognitive function, which could impact major activities of daily living and independence. It has been used for patients with mild cognitive impairment, Alzheimer's Disease, and dementia. It takes 5 minutes to complete.
Change in PASC Symptom Questionnaire responses Baseline, End of Intervention (Day 63) Participants will be asked to complete a questionnaire that asks about the presence of PASC symptoms at Baseline and at follow-up visits. This questionnaire includes symptoms that have been associated with PASC.
Change in total score from ISI (Insomnia Severity Index) Baseline, End of Intervention (Day 63) The ISI is a 7-item, self-report questionnaire that assesses the nature, severity, and impact of insomnia, on a 5-point Likert scale (eg, 0 = not at all, 4 = extremely; scores: from 0 to 28). The ISI asks patients to recall their insomnia symptoms over the past 2 weeks.
Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary Baseline, End of Intervention (Day 63) Sleep onset time will be assessed by sleep diary
Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary Baseline, End of Intervention (Day 63) Nocturnal sleep duration will be assessed by sleep diary
Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary Baseline, End of Intervention (Day 63) 24-hour sleep duration will be assessed by sleep diary
Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary Baseline, End of Intervention (Day 63) Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary
Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker Baseline, End of Intervention (Day 63) Nocturnal sleep duration will be assessed by activity tracker
Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker Baseline, End of Intervention (Day 63) 24-hour sleep duration will be assessed by activity tracker
Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker Baseline, End of Intervention (Day 63) Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker
Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker Baseline, End of Intervention (Day 63) Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary
Trial Locations
- Locations (1)
All sites listed under NCT06404086
🇺🇸Durham, North Carolina, United States