Completed

NCT Number: NCT06404112

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).

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Key information

Conditions

Long COVID COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Long COVID-19 Lung Diseases Mental Disorders Nervous System Diseases Nidovirales Infections Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sleep Disturbance Sleep Wake Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

All sites listed under NCT06404086

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sleep medication, if not willing to washout for 4 weeks.

Treatment and study plan

Melatonin

Drug

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

Drug

Melatonin placebo dosing will be one placebo tablet once daily consumed 2 hours before the participant's desired bedtime.

Tailored lighting (TL) Active

Device

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

Device

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.

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 total score of the PROMIS 8a SRI to assess sleep-related impairment

Time frame: 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 PROMIS 10a Fatigue score

Time frame: 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

Time frame: Baseline, End of Intervention (Day 63)
Change in ECog2 measure

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, End of Intervention (Day 63)

Sleep midpoint is the time half way between start and end of sleep, as assessed by sleep diary

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: May 8, 2024
Registry last updated: Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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