Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
RECOVER-SLEEP: Platform Protocol
NCT06404086 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Melatonin
- DRUG Modafinil
- DRUG Solriamfetol
- DRUG Modafinil Placebo
- DRUG Solriamfetol Placebo
Study Locations (20)
Georgia
- Grady Memorial Hospital — Atlanta
- Morehouse School of Medicine — Atlanta
- Emory University — Atlanta
- Atlanta VA Medical Center — Decatur
- Emory Hope Clinic — Decatur
Illinois
- Northwestern Memorial Hospital — Chicago
- Cook County Health Specialty Care Center — Chicago
- Rush University Medical Center — Chicago
- University of Illinois at Chicago — Chicago
- NorthShore Medical Group — Evanston
Arizona
- Banner University Medical Center Phoenix — Phoenix
- University of Arizona Banner Medical Center — Tucson
- The Southern Arizona VA Health Care System — Tucson
California
- Stanford University — Palo Alto
- University of California San Francisco General Hospital — San Francisco
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
- Denver Health and Hospital Authority — Denver
Florida
- University of Florida College of Medicine Jacksonville — Jacksonville
- Lakeland Regional Medical Center — Lakeland
District of Columbia
- Howard University Hospital — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 830 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06404086
The ClinicalTrials.gov registry entry for NCT06404086 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 830 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Sleep Disturbance appearing as the primary indexed condition, and to 5 interventions — of which Melatonin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06404086 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Georgia, Illinois, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06404086 about?
NCT06404086 is a clinical study titled "RECOVER-SLEEP: Platform Protocol". 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. ...
What is the current status of trial NCT06404086?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 830 participants. The study started on 2024-07-31. Estimated completion is 2025-12-31.
What conditions does trial NCT06404086 study?
This clinical trial studies the following conditions: Sleep Disturbance, Long COVID, Long COVID-19, Hypersomnia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06404086?
The interventions under investigation include: Melatonin (DRUG), Modafinil (DRUG), Solriamfetol (DRUG), Modafinil Placebo (DRUG), Solriamfetol Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06404086?
This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06404086 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.