What is the Purpose of this Study?
The purpose of this study is to determine whether certain interventions can help treat sleep disturbances that started or worsened following a COVID infection and have lasted for at least 12 weeks. Sleep disturbances include excessive drowsiness, problems falling and staying asleep, and problems with sleep-wake patterns. These disturbances are known to be associated with post-acute sequelae of SARS-CoV-2 infection (PASC) or Long COVID. This study will examine the effects that the interventions may have on the ability to recover from sleep disturbances associated with Long COVID.
Participants will also be screened and assigned to a sub-study that best matches the type of sleep disturbance they are experiencing. Each sub-study contains 1 or more active study intervention group and an inactive study intervention group. An intervention could include a study drug, a study device, a behavioral approach, or a combination of these interventions.
Eligibility
Inclusion Criteria:
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
- 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
- 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
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
RECOVER-SLEEP A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in PASC