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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial for Long COVID-related sleep disturbance that has already completed recruitment — does that mean results are available yet, and if so, what did they find about whether the treatment actually helped with sleep problems?
2The trial tracked sleep onset variability using a wearable device alongside a standard questionnaire called the PROMIS 8b — does my own sleep disturbance look similar to what this trial was studying, and would those same measures be useful for tracking my symptoms now?
3Since this trial is finished and I can no longer enroll, are there other active trials or treatments for Long COVID sleep disturbance that my care team thinks I should consider next?
4Phase 2 trials are primarily focused on early safety and dosing questions rather than proving a treatment works — given that, how confident should I be in any findings that come out of this study when thinking about my own treatment options?
5Would the approach used in this trial — whatever intervention was being tested for Long COVID sleep disturbance — be something my doctor could discuss with me as a possible path forward, even outside of a trial setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in total score of the PROMIS 8b SD to assess sleep disturbance
Timeframe: Baseline, End of Intervention (Day 63)
2
Change in sleep onset variability, assessed using a wearable device