Sleep Treatments for Long COVID Syndrome

Phase 2

Recruiting

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years of age at the time of enrollment

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is looking at different interventions to help improve sleep problems in patients with Post-Acute Sequelae of SARS-CoV-2 (PASC). The trial uses a flexible protocol that

Who is the study for?

This trial is for adults over 18 who've had COVID-19 and are now experiencing new or worsened sleep problems lasting at least 12 weeks. Participants must have been in contact with a COVID case, hospitalized with respiratory symptoms, or tested positive. They should be able to consent, complete surveys/assessments, follow up on visits, and use birth control if applicable.

What is being tested?

The RECOVER-SLEEP trial tests multiple treatments for post-COVID sleep issues: Melatonin, Modafinil, Solriamfetol and Tailored lighting (TL), each against a placebo. It's multi-center and randomized; patients don't choose their treatment.

What are the potential side effects?

Possible side effects include headaches, dizziness from melatonin; insomnia, anxiety from modafinil; heart palpitations from solriamfetol; no significant side effects expected from tailored lighting but may vary individually.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total number of participants enrolled in each Appendix

Trial Design

2Treatment groups

Experimental Treatment

Group I: Hypersomnia Arm (Appendix A)Experimental Treatment4 Interventions

This is a double-blind, phase 2, randomized, placebo-controlled interventional trial of a wake-promoting drug (modafinil or solriamfetol) to treat hypersomnia, defined by elevated scores (\> 60) on the PROMIS 8a SRI scale, in participants with PASC. Participants will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or modafinil-matched control. If modafinil is contraindicated, participants will be assessed for solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks. Anticipated enrollment is 474 participants. Details about the Hypersomnia Appendix are available under NCT06404099.

Group II: Complex PASC related Sleep Disturbances (CPSD) Arm (Appendix B )Experimental Treatment4 Interventions

This is a double-blind, phase 2, randomized, placebo-controlled, interventional trial that combines brief education and a tailored sleep timing prescription for CPSD with therapies that modify circadian timing for participants who report poor sleep quality or daytime sleep-related impairment, defined by elevated scores (≥60) on the PROMIS 8b SD scale, in participants with symptoms that occurred or worsened after COVID-19 infection. Interventions involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to 1 of 4 groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive BBT-CPSD. It is a 2x2 factorial design schema. The intervention duration will be 8 weeks. Anticipated enrollment for this appendix is 600 participants. Additional details about the CPSD Appendix are available under NCT06404112.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

Modafinil

2002

Completed Phase 4

~1700