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Evaluating treatments for sleep disturbances in Long COVID patients

RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Phase 2 Interventional Duke University · NCT06404086

This study is testing different treatments to see if they can help people with Long COVID who are having trouble sleeping.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment1074 (estimated)
Ages18 Years and up
SexAll
SponsorDuke University Academic / other
Locations45 sites (Phoenix, Arizona and 44 other locations)
Trial IDNCT06404086 on ClinicalTrials.gov

What this trial studies

This platform protocol is a multi-center, multi-arm, randomized controlled trial designed to evaluate various interventions for sleep disturbances associated with Long COVID. Participants will be assessed for their sleep phenotype and then randomized to receive either a targeted intervention or a placebo. The study aims to improve symptoms of hypersomnia and other sleep-related issues in patients recovering from COVID-19. The flexible design allows for the addition of various interventions, enabling comparative analysis across different treatment approaches.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced symptoms of Long COVID following a SARS-CoV-2 infection.

Not a fit: Patients who do not have sleep disturbances related to Long COVID may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to effective treatments for sleep disturbances in Long COVID patients, improving their quality of life.

How similar studies have performed: Other studies have shown promise in treating sleep disturbances in similar populations, but this platform approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Long COVIDLong COVID-19HypersomniaSleep DisturbancePASC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.