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Can we fix long COVID sleep issues? new study says maybe.

NCT ID NCT06404086

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different treatments for sleep problems caused by Long COVID. It included 830 adults who had COVID-19 and now have trouble sleeping or feel very sleepy during the day. The goal was to see if treatments matched to specific sleep issues could help people feel better.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

830 people

The number who actually took part.

Started

Jul 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 the Pan American Health Organization: Suspected\* case of SARS-CoV-2 infection - Three options, A through C: A. Met the clinical OR epidemiological criteria: 1. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute 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; 2. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presented with acute respiratory infection with a history of fever or measured fever of ≥ 38°C and cough, with onset within the last 10 days, and required hospitalization; or C. Presented with no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test. Probable\* case of SARS-CoV-2 infection, defined as having met the clinical criteria above AND was a contact of a probable or confirmed case or is linked to a COVID-19 cluster; or Confirmed case of SARS-CoV-2 infection - Two options, A through B: A. Presented with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or B. Met clinical criteria AND/OR epidemiological criteria (See suspected case A), with a positive professional use or self-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 cases are required. 3. New/worse sleep problems following a SARS-CoV-2 infection that have persisted for at least 12 weeks and are still present at the time of consent 4. PROMIS 8a SRI or 8b SD T Score ≥ 55\*\* \*\* Screening with both the PROMIS 8a SRI and 8b SD will occur for the phenotype assessment portion of the protocol. 5. Willing and able to provide informed consent, complete the surveys and clinical assessments, and return for all of the necessary follow-up visits 6. Adequate method of birth control for participants of child-bearing potential 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 bipolar disorder 8. Current or recent use (within the last 14 days) of study intervention or similar intervention to treat the underlying condition, unless a washout period is permitted per appendix\* 9. Known allergy/sensitivity or any hypersensitivity to components of the study intervention or control\* 10. Known contraindication(s) to study intervention including prohibited concomitant medications and without the ability to safely hold prohibited concomitant medications (see appendices)\* 11. Currently receiving/using intervention from another clinical trial that could impact or 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.

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence hypersomnia long COVID-19 Parasomnias sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypersomnia Long COVID Long COVID-19 Sleep disturbance

Contacts and locations

Locations

  • Atlanta VA Medical Center

    Decatur, Georgia, 30030, United States

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006, United States

  • Beth Israel Deaconess Med. Ctr.

    Boston, Massachusetts, 02215, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115, United States

  • Cook County Health Specialty Care Center

    Chicago, Illinois, 60612, United States

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204, United States

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Emory Hope Clinic

    Decatur, Georgia, 30030, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Evergreen Hospital Medical Center

    Kirkland, Washington, 98034, United States

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Howard University Hospital

    Washington D.C., District of Columbia, 20060, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Jadestone Clinical Research, LLC

    Silver Spring, Maryland, 20904, United States

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310, United States

  • New Dawn Wellness and Medical Research Center

    Houston, Texas, 77082, United States

  • NorthShore Medical Group

    Evanston, Illinois, 60201, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Rutgers University - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901, United States

  • Saint Francis Medical Center

    Peoria, Illinois, 61606, United States

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • The Southern Arizona VA Health Care System

    Tucson, Arizona, 85723, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University Physicians and Surgeons (DBA Marshall Health)

    Huntington, West Virginia, 25701, United States

  • University of Arizona Banner Medical Center

    Tucson, Arizona, 85719, United States

  • University of California San Francisco General Hospital

    San Francisco, California, 94143, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45220, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Florida College of Medicine Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87102, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • West Virginia Clinical and Translational Science Institute

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.