RECOVER-SLEEP: Platform Protocol
Public ClinicalTrials.gov record NCT06404086. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06404086
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 830 participants
Conditions and interventions
Conditions
Interventions
- Modafinil Drug
- Modafinil Placebo Drug
- Solriamfetol Drug
- Solriamfetol Placebo Drug
- Melatonin Drug
- Melantonin Placebo Drug
- Tailored lighting (TL) Active Device
- Tailored lighting (TL) Placebo Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2024
- Primary completion
- Dec 30, 2025
- Completion
- Dec 30, 2025
- Last update posted
- Jan 21, 2026
2024 – 2025
United States locations
- U.S. sites
- 47
- U.S. states
- 22
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | — |
| University of Arizona Banner Medical Center | Tucson | Arizona | 85719 | — |
| The Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| University of California San Francisco General Hospital | San Francisco | California | 94143 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | — |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | — |
| University of Florida College of Medicine Jacksonville | Jacksonville | Florida | 32209 | — |
| Lakeland Regional Medical Center | Lakeland | Florida | 33805 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| Morehouse School of Medicine | Atlanta | Georgia | 30310 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Atlanta VA Medical Center | Decatur | Georgia | 30030 | — |
| Emory Hope Clinic | Decatur | Georgia | 30030 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Cook County Health Specialty Care Center | Chicago | Illinois | 60612 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| NorthShore Medical Group | Evanston | Illinois | 60201 | — |
| Saint Francis Medical Center | Peoria | Illinois | 61606 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | — |
| Jadestone Clinical Research, LLC | Silver Spring | Maryland | 20904 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess Med. Ctr. | Boston | Massachusetts | 02215 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Rutgers University - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| University of New Mexico | Albuquerque | New Mexico | 87102 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45220 | — |
| University Hospitals of Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| New Dawn Wellness and Medical Research Center | Houston | Texas | 77082 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Evergreen Hospital Medical Center | Kirkland | Washington | 98034 | — |
| University Physicians and Surgeons (DBA Marshall Health) | Huntington | West Virginia | 25701 | — |
| West Virginia Clinical and Translational Science Institute | Morgantown | West Virginia | 26506 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06404086, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06404086 live on ClinicalTrials.gov.