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
. Self-reported sleep duration \<6 hours per night
. Recent myocardial infarction (\<1 year), unstable angina, serious cardiac arrhythmias, or other serious heart problems, at the discretion of the investigator
. Current use of stimulant or wake-promoting medications, unless a washout is permitted
. Regular use of prescribed hypnotics for sleep (≥3 times per week); washout period is permitted.
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 trial is listed as completed — does that mean results are available, and if so, what did they find about treating hypersomnia in Long COVID patients?
2Since this was a Phase 2 trial, what does that tell us about how much is still unknown regarding the safety and effectiveness of whatever treatment was being tested here?
3The trial measured sleep-related impairment using something called the PROMIS 8a — can you help me understand whether improvements on that scale would translate to meaningful changes in day-to-day life for someone with Long COVID hypersomnia?
4Given that this trial is now completed and no longer enrolling, are there other active studies or standard treatment options for Long COVID-related hypersomnia that might be worth considering instead?
5Would my specific pattern of hypersomnia symptoms — like how severe they are or how long I've had them — have matched what this trial was looking for, and does that tell us anything about which treatments my doctor should consider for me?
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 8a SRI to assess sleep-related impairment
. Modafinil can affect drug metabolism given its effect on enzymes such as CYP3A4 and CYP2C19. To assess for drug interactions, investigators should use the Lexicomp Drug Interactions System that is available at most institutions.