RECOVER-SLEEP: Platform Protocol

Last updated: June 11, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Disorders

Insomnia

Restless Leg Syndrome

Treatment

Solriamfetol

Melatonin

Modafinil Placebo

Clinical Study ID

NCT06404086
Pro00112484
OTA-21-015G
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. ≥ 18 years of age at the time of enrollment

  2. Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by thePan American Health Organization: Suspected* case of SARS-CoV-2 infection - Three options, A through C: A. Met the clinical OR epidemiological criteria:

  3. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) ORAcute onset of ANY THREE OR MORE of the following signs or symptoms: fever,cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza,dyspnea, nausea, diarrhea, anorexia;

  4. Epidemiological criteria: Contact of a probable or confirmed case or linked toa COVID-19 cluster; or B. Presented with acute respiratory infection with ahistory of fever or measured fever of ≥ 38°C and cough, with onset within thelast 10 days, and required hospitalization; or C. Presented with no clinicalsigns or symptoms, NOR meeting epidemiologic criteria with a positiveprofessional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test. Probable* case of SARS-CoV-2 infection, defined as having met the clinical criteriaabove AND was a contact of a probable or confirmed case or is linked to a COVID-19cluster; or Confirmed case of SARS-CoV-2 infection - Two options, A through B: A. Presented with a positive nucleic acid amplification test, regardless of clinicalcriteria OR epidemiological criteria; or B. Met clinical criteria AND/ORepidemiological criteria (See suspected case A), with a positive professional use orself-test SARS-CoV-2 Antigen-Rapid Diagnostic Test.

  • Suspected and probable cases will only be allowed if they occurred before May 1, 2021, and will be limited to 10% of the study population. Otherwise, confirmed casesare required.
  1. New/worse sleep problems following a SARS-CoV-2 infection that have persisted for atleast 12 weeks and are still present at the time of consent

  2. PROMIS 8a SRI or 8b SD T Score ≥ 55**

** Screening with both the PROMIS 8a SRI and 8b SD will occur for the phenotypeassessment portion of the protocol.

  1. Willing and able to provide informed consent, complete the surveys and clinicalassessments, and return for all of the necessary follow-up visits

  2. Adequate method of birth control for participants of child-bearing potential

Exclusion

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent

  2. Known pregnancy, breastfeeding, or contemplating pregnancy during the study period

  3. Untreated sleep apnea (AHI ≥ 15 or severe sleep-related hypoxemia)

  4. Current night or rotating shift work

  5. Known history of narcolepsy prior to SARS-CoV-2 infection

  6. Any non-marijuana illicit drug use within 30 days of informed consent

  7. Known history of severe mental disorder, such as psychotic disorders and bipolardisorder

  8. Current or recent use (within the last 14 days) of study intervention or similarintervention to treat the underlying condition, unless a washout period is permittedper appendix*

  9. Known allergy/sensitivity or any hypersensitivity to components of the studyintervention or control*

  10. Known contraindication(s) to study intervention including prohibited concomitantmedications and without the ability to safely hold prohibited concomitantmedications (see appendices)*

  11. Currently receiving/using intervention from another clinical trial that could impactor mask treatment effect; refer to MOP for details

  12. Any condition that would make the participant, in the opinion of the investigator,unsuitable for the study

(*)If only one study intervention appendix is open at the time of enrollment. If multiple study intervention appendices are open, a participant may be excluded from any study intervention appendix based on contraindications listed in the study intervention appendix, current use of study intervention, or known allergy/sensitivity/hypersensitivity yet remain eligible for the remaining study intervention appendices.

Study Design

Total Participants: 1074
Treatment Group(s): 8
Primary Treatment: Solriamfetol
Phase: 2
Study Start date:
July 31, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.

After completing Baseline assessments, participants will be randomized to an intervention group, which is based on their sleep phenotype, or into a placebo/control group.

Connect with a study center

  • Banner University Medical Center Phoenix

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • University of Arizona Banner Medical Center

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • University of California San Francisco General Hospital

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Denver Health and Hospital Authority

    Denver, Colorado 80204
    United States

    Active - Recruiting

  • Howard University Hospital

    Washington, District of Columbia 20060
    United States

    Active - Recruiting

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida 32209
    United States

    Active - Recruiting

  • Atlanta VA Medical Center

    Atlanta, Georgia 30033
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Morehouse School of Medicine

    Atlanta, Georgia 30310
    United States

    Active - Recruiting

  • Emory Hope Clinic

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Cook County Health Specialty Care Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • NorthShore Medical Group

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • Saint Francis Medical Center

    Peoria, Illinois 61606
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Jadestone Clinical Research, LLC

    Silver Spring, Maryland 20904
    United States

    Active - Recruiting

  • Beth Israel Deaconess Med. Ctr.

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Brigham and Womens Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Rutgers University - Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • University of New Mexico

    Albuquerque, New Mexico 87106
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45220
    United States

    Active - Recruiting

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Southwest Family Medicine Associates

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • New Dawn Wellness and Medical Research Center

    Houston, Texas 77082
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • University Physicians and Surgeons (DBA Marshall Health)

    Huntington, West Virginia 25701
    United States

    Active - Recruiting

  • West Virginia Clinical and Translational Science Institute

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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