Clinical trial NCT06404112: RECOVER-SLEEP: Platform Protocol, Appendix_B (CPSD)
Official title: RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Long COVID
Long COVID-19
Sleep Disturbance
Keywords: PASC
Sleep Disturbances
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This platform protocol is designed to allocate participants into an intervention appendix based on their symptoms of sleep disturbance. Within the appendix, participants will be randomly assigned based on the appendix study design. Site investigators and personnel will be informed as to which study intervention appendix participants are assigned, but they will be blinded to whether participants are receiving the active study intervention or control, when possible. Similarly, participants will be blinded to active intervention or control, when possible. Randomization will be stratified by the study site; other stratification factors may be considered per appendix.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in total score of the PROMIS 8b SD to assess sleep disturbance
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in sleep onset variability, assessed using a wearable device
timeFrame: Baseline, End of Intervention (Day 63)
Secondary outcomes:
measure: Change in total score of the PROMIS 8a SRI to assess sleep-related impairment
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in PROMIS 10a Fatigue score
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in an objective neurocognitive battery score
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in ECog2 measure
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in PASC Symptom Questionnaire responses
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in total score from ISI (Insomnia Severity Index)
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in within-person variability (over a 7-day period) in sleep onset time, assessed by sleep diary
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in average (over a 7-day period) nocturnal sleep duration, assessed by sleep diary
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in average (over a 7-day period) 24-hour sleep duration, assessed by sleep diary
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in average (over a 7-day period) sleep midpoint, assessed by sleep diary
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in average (over a 7-day period) nocturnal sleep duration, assessed by activity tracker
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in average (over a 7-day period) 24-hour sleep duration, assessed by activity tracker
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in average (over a 7-day period) sleep efficiency, assessed by activity tracker
timeFrame: Baseline, End of Intervention (Day 63)
measure: Change in average (over a 7-day period) sleep midpoint, assessed by activity tracker
timeFrame: Baseline, End of Intervention (Day 63)
Other outcomes:
Locations:
city: Durham
country: United States
facility: All sites listed under NCT06404086
state: North Carolina
Study officials:
affiliation: Duke Clinical Research Institute
name: Christina Barkauskas, MD
role: STUDY_CHAIR
affiliation: Brigham and Women's Hospital
name: Susan Redline, MD MPH
role: STUDY_CHAIR
References: