Evaluating treatments for sleep disturbances in Long COVID patients
RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
This study is testing different treatments for sleep problems in people with Long COVID to see if they can help improve their sleep and overall well-being.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 474 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06404099 on ClinicalTrials.gov |
What this trial studies
This platform protocol is a multi-center, multi-arm, randomized controlled trial designed to evaluate various interventions for sleep disturbances associated with Long COVID, specifically focusing on hypersomnia. Participants will undergo baseline assessments and then be randomized into either an intervention group based on their sleep phenotype or a placebo/control group. The study aims to improve symptoms of sleep and circadian disorders through targeted interventions, with specific treatments including Modafinil and Solriamfetol. The flexible design allows for the addition of various interventions while maintaining a consistent protocol structure.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing sleep-related daytime impairment due to Long COVID.
Not a fit: Patients with self-reported sleep duration of less than 6 hours per night or those with poorly controlled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective treatments for sleep disturbances in patients suffering from Long COVID.
How similar studies have performed: Other studies have shown promise in addressing sleep disturbances in similar patient populations, but this platform approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 (or sub-study) Additional Appendix A (Hypersomnia) Level Exclusion Criteria: 1. Self-reported sleep duration \<6 hours per night 2. Poorly controlled hypertension (systolic blood pressure ≥140 or diastolic blood pressure ≥90 mmHg) 3. Moderate to severe hepatic impairment (ie, Child-Pugh class B or C)\* 4. Known estimated glomerular filtration rate \<30 mL/min/1.73 m2 and/or chronic dialysis\* 5. Recent myocardial infarction (\<1 year), unstable angina, serious cardiac arrhythmias, or other serious heart problems, at the discretion of the investigator 6. Current use of stimulant or wake-promoting medications, unless a washout is permitted 7. Regular use of prescribed hypnotics for sleep (≥3 times per week); washout period is permitted. * characterized by the screening labs: coagulation panel and CMP w/LFTs MODAFINIL EXCLUSION CRITERIA 1. 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. o If the search yields "D" - Consider Modifying Therapy or "X" - Avoid Combination, then the ACTION is to exclude the potential participant. An important example of this is steroid hormonal contraceptives. * If the search yields "C" - Monitor Therapy, then discuss with site PIs on a case-by-case basis. * If the search yields "A" - No Known Interaction or "B" - No Action Needed, then proceed to screen/include the potential participant. 2. Known severe left ventricular hypertrophy, mitral valve prolapse SOLRIAMFETOL EXCLUSION CRITERIA 1. Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days 2. Current use of dopaminergic drugs
Where this trial is running
Durham, North Carolina
- All sites listed under NCT06404086 — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Jaelyn R Linski, BA, CCRC
- Email: recoverresearch@duke.edu
- Phone: 919-668-8060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.