RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)

Sleep Disturbance Clinical Trial

Official title:

RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404112
• Other study ID #: Pro00112484_B
• Secondary ID: OTA-21-015G
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: Jaelyn R Linski, BA, CCRC
• Phone: 919-668-8060
• Email: recoverresearch[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Dyssomnias
• Long COVID
• Long COVID-19
• Parasomnias
• Sleep Disturbance

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total score of the PROMIS 8b SD to assess sleep disturbance	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 60 being 1 standard deviation above population mean. Higher scores indicate more sleep disturbance.	Baseline, End of Intervention (Day 63)
Primary	Change in sleep onset variability, assessed using a wearable device	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	Baseline, End of Intervention (Day 63)
Secondary	Change in total score of the PROMIS 8a SRI to assess sleep-related impairment	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 > 60 1 SD above population mean.	Baseline, End of Intervention (Day 63)
Secondary	Change in PROMIS 10a Fatigue score	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).	Baseline, End of Intervention (Day 63)
Secondary	Change in an objective neurocognitive battery score		Baseline, End of Intervention (Day 63)
Secondary	Change in ECog2 measure	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.	Baseline, End of Intervention (Day 63)
Secondary	Change in PASC Symptom Questionnaire responses	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.	Baseline, End of Intervention (Day 63)
Secondary	Change in total score from ISI (Insomnia Severity Index)	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.	Baseline, End of Intervention (Day 63)
Secondary	Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary	Sleep onset time will be assessed by sleep diary	Baseline, End of Intervention (Day 63)
Secondary	Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary	Nocturnal sleep duration will be assessed by sleep diary	Baseline, End of Intervention (Day 63)
Secondary	Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary	24-hour sleep duration will be assessed by sleep diary	Baseline, End of Intervention (Day 63)
Secondary	Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary	Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary	Baseline, End of Intervention (Day 63)
Secondary	Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker	Nocturnal sleep duration will be assessed by activity tracker	Baseline, End of Intervention (Day 63)
Secondary	Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker	24-hour sleep duration will be assessed by activity tracker	Baseline, End of Intervention (Day 63)
Secondary	Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker	Sleep Efficiency is the percentage of the sleep period spent asleep, as measured by activity tracker	Baseline, End of Intervention (Day 63)
Secondary	Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker	Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary	Baseline, End of Intervention (Day 63)

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