Clinical trialNCT06404086CompletedPhase 2Interventional

RECOVER-SLEEP: Platform Protocol

SponsorDuke UniversityEnrollment830HypersomniaLong COVIDLong COVID-19Sleep Disturbance

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Christina Barkauskas, MD
Duke Clinical Research Institute
Study Chair
clinicaltrials.gov ↗
Susan Redline, MD MPH
Brigham and Women's Hospital
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

47 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Banner University Medical Center Phoenix
Phoenix, Arizona, United States
the Southern Arizona Va Health Care System
Tucson, Arizona, United States
University of Arizona Banner Medical Center
Tucson, Arizona, United States
Stanford University
Palo Alto, California, United States
University of California San Francisco General Hospital
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Emory University
Atlanta, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Atlanta Va Medical Center
Decatur, Georgia, United States
Emory Hope Clinic
Decatur, Georgia, United States
Cook County Health Specialty Care Center
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Northshore Medical Group
Evanston, Illinois, United States
Saint Francis Medical Center
Peoria, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Jadestone Clinical Research, Llc
Silver Spring, Maryland, United States
Beth Israel Deaconess Med. Ctr.
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
East Carolina University
Greenville, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States

7 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Melantonin PlaceboMelatoninModafinil →Modafinil PlaceboSolriamfetol →Solriamfetol Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jul 2024
Primary completion: 31 Dec 2025
Completion: 31 Dec 2025
Last update posted: 22 Jan 2026
Registered enrollment: 830
Registry id: NCT06404086

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 30 Jul 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.