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Clinical Trial NCT06404086 for Long COVID, Long COVID-19, Hypersomnia, Sleep Disturbance is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Duke UniversityRECOVER-SLEEP: Platform Protocol
Clinical Trial NCT06404086 is designed to study Treatment for Long COVID, Long COVID-19, Hypersomnia, Sleep Disturbance. It is a Phase 2 interventional trial that is recruiting, having started on July 31, 2024, with plans to enroll 1,074 participants. Led by Duke University, it is expected to complete by December 31, 2025. The latest data from ClinicalTrials.gov was last updated on August 19, 2025.
Brief 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).
Detailed 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.
Official Title
RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Conditions
Long COVIDLong COVID-19HypersomniaSleep DisturbanceOther Study IDs
- Pro00112484
- OTA-21-015G (Other Grant/Funding Number) (NIH Grant to RTI; RTI subcontracting with DCRI)
NCT ID Number
Start Date (Actual)
2024-07-31
Last Update Posted
2025-08-19
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
1,074
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
PASC
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherHypersomnia Arm (Appendix A) This is a double-blind, phase 2, randomized, placebo-controlled interventional trial of a wake-promoting drug (modafinil or solriamfetol) to treat hypersomnia, defined by elevated scores (\> 55) on the PROMIS 8a SRI scale, in participants with PASC. Participants will be randomized to study drug or control. Participants who meet the eligibility criteria for modafinil will receive either active modafinil or modafinil-matched control. If modafinil is contraindicated, participants will be assessed for solriamfetol. If participants are eligible for solriamfetol, they will receive either active solriamfetol or solriamfetol-matched control. If solriamfetol is contraindicated, participants will be excluded from Appendix A. Modafinil and solriamfetol will be analyzed as a single wake-promoting drug condition versus control. The intervention duration will be 10 weeks.
Anticipated enrollment is 474 participants. Details about the Hypersomnia Appendix are available under NCT06404099. | Modafinil Modafinil is used off-label based on supporting published evidence in major depressive disorder (antidepressant augmentation), multiple sclerosis-related fatigue, Parkinson disease-related excessive daytime sleepiness, and severe cancer-related fatigue (in patients receiving active treatment). Doses up to 400 mg/day, given as a singleMode dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose.
Study drug administration will total 10 weeks. Modafinil Placebo The placebo will be tooled to look similar to the modafinil tablet, but it will not contain the active ingredient. Modafinil placebo dosing will follow the same titration scheme as modafinil treatment.
Unblinded study personnel will manage modafinil and placebo disbursement to maintain blinding among participants and blinded study personnel, including site investigators. Solriamfetol The proposed doses and the schedule of dose escalation are consistent with currently approved FDA labeling for solriamfetol for other disorders of excessive daytime sleepiness.
Solriamfetol dosing will total 10 weeks, including 3 weeks for titration and 7 weeks of maintenance. Solriamfetol will be given as a 75 mg tablet (1 or 2 per day) in the morning. The 3-week titration will be facilitated by phone calls between the study team and participants. Titrations in dose will be dependent upon participants' symptoms and tolerance to solriamfetol, with a goal of participants taking the highest dose permitted by symptoms. This dose will be used for the maintenance phase. Solriamfetol Placebo The placebo tablet will be tooled to look similar to the solriamfetol tablet, but it will not contain the active ingredient. Solriamfetol placebo dosing will follow the solriamfetol dosing scheme and goal.
Unblinded study personnel will manage solriamfetol and placebo disbursement to maintain blinding among participants and blinded study personnel, including site investigators. |
OtherComplex PASC related Sleep Disturbances (CPSD) Arm (Appendix B ) This is a double-blind, phase 2, randomized, placebo-controlled, interventional trial that combines brief education and a tailored sleep timing prescription for CPSD with therapies that modify circadian timing for participants who report poor sleep quality or daytime sleep-related impairment, defined by elevated scores (≥55) on the PROMIS 8b SD scale, in participants with symptoms that occurred or worsened after COVID-19 infection. Interventions involve tailored lighting (TL) and melatonin. Participants will be randomly assigned to 1 of 4 groups: (a) active TL + oral melatonin, (b) active TL + placebo melatonin, (c) placebo TL + oral melatonin, and (d) placebo TL + placebo melatonin. All groups will receive BBT-CPSD. It is a 2x2 factorial design schema. The intervention duration will be 8 weeks.
Anticipated enrollment for this appendix is 600 participants. Additional details about the CPSD Appendix are available under NCT06404112. | Melatonin Melatonin dosing will be one tablet of 3 mg immediate release daily consumed 2 hours before the participant's desired bedtime, which is defined as the time at which the participant tries to fall asleep. Melantonin Placebo Melatonin placebo dosing will be one placebo tablet once daily consumed 2 hours before the participant's desired bedtime. Tailored Lighting (TL) Active TL will be delivered similarly to both active and placebo groups, but the circadian stimulus (the amount of light) will be different, albeit practically unidentifiable to participants. Tailored Lighting (TL) Placebo TL will be delivered similarly to both active and placebo groups, but the circadian stimulus (the amount of light) will be different, albeit practically unidentifiable to participants. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Total number of participants enrolled in each Appendix | Total number of participants enrolled in each Appendix will be reported. Appendix-specific outcome measure data will be reported under the associated NCT#. | 12 months |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
≥ 18 years of age at the time of enrollment
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:
- 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;
- 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.
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
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.
Willing and able to provide informed consent, complete the surveys and clinical assessments, and return for all of the necessary follow-up visits
Adequate method of birth control for participants of child-bearing potential
An individual who meets any of the following criteria will be excluded from participation in this study:
- Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent
- Known pregnancy, breastfeeding, or contemplating pregnancy during the study period
- Untreated sleep apnea (AHI ≥ 15 or severe sleep-related hypoxemia)
- Current night or rotating shift work
- Known history of narcolepsy prior to SARS-CoV-2 infection
- Any non-marijuana illicit drug use within 30 days of informed consent
- Known history of severe mental disorder, such as psychotic disorders and bipolar disorder
- 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*
- Known allergy/sensitivity or any hypersensitivity to components of the study intervention or control*
- Known contraindication(s) to study intervention including prohibited concomitant medications and without the ability to safely hold prohibited concomitant medications (see appendices)*
- Currently receiving/using intervention from another clinical trial that could impact or mask treatment effect; refer to MOP for details
- 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.
Duke University544 active trials to exploreStudy Central Contact
Contact: Jaelyn R Linski, BA, CCRC, 919-668-8060, [email protected]
Contact: Barrie L Harper, BSMT (ASCP) PMP, [email protected]
47 Study Locations in 1 Countries
Arizona
Banner University Medical Center Phoenix, Phoenix, Arizona, 85006, United States
Active, not recruiting
University of Arizona Banner Medical Center, Tucson, Arizona, 85719, United States
Heidi Erickson, Contact, 520-626-5287, [email protected]
Parthasarathy Sairam, MD, Principal Investigator
Recruiting
The Southern Arizona VA Health Care System, Tucson, Arizona, 85723, United States
Adnan Abbasi, MD, Contact
Adnan Abbasi, Principal Investigator
Recruiting
California
Stanford University, Palo Alto, California, 94304, United States
Clete Kushida, MD, Contact, 650-723-6601, [email protected]
Clete Kushida, MD, Principal Investigator
Recruiting
University of California San Francisco General Hospital, San Francisco, California, 94143, United States
Aric Prather, MD, Contact
Aric Prather, Principal Investigator
Andrew Krystal, Sub-Investigator
Recruiting
Colorado
University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States
Sarah Jolley, MD, Contact
Sarah Jolley, MD, Principal Investigator
Kristine Erlandson, Sub-Investigator
Neale Lange, Sub-Investigator
Recruiting
Denver Health and Hospital Authority, Denver, Colorado, 80204, United States
Edward Gardner, MD, Contact
Edward Gardner, Principal Investigator
Recruiting
District of Columbia
Howard University Hospital, Washington D.C., District of Columbia, 20060, United States
Peter Whitesell, Contact
Peter Whitesell, MD, Principal Investigator
Zara Martirosyan, Sub-Investigator
Alem Mehari, Sub-Investigator
Recruiting
Florida
University of Florida College of Medicine Jacksonville, Jacksonville, Florida, 32209, United States
Carmen Isache, MD, Contact
Carmen Isache, MD, Principal Investigator
Jorge Verdecia, MD, Sub-Investigator
Recruiting
Lakeland Regional Medical Center, Lakeland, Florida, 33805, United States
Debra Seoane, MD, Contact
Debra Seoane, MD, Principal Investigator
Recruiting
Georgia
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
Jenny Han, MD, Contact
Jenny Han, Principal Investigator
Tiffany Walker, Sub-Investigator
Recruiting
Morehouse School of Medicine, Atlanta, Georgia, 30310, United States
Priscilla Igho-Pemu, Contact
Priscilla Igho-Pemu, Principal Investigator
Recruiting
Emory University, Atlanta, Georgia, 30322, United States
Dayna Johnson, MD, Contact, 404-727-8708, [email protected]
Dayna Johnson, MD, Principal Investigator
Nancy Collop, MD, Sub-Investigator
Alex Truong, MD, Sub-Investigator
Recruiting
Atlanta VA Medical Center, Decatur, Georgia, 30030, United States
Barry Fields, MD, Contact
Barry Fields, MD, Principal Investigator
Recruiting
Emory Hope Clinic, Decatur, Georgia, 30030, United States
Wiley Zanthia, MD, Contact
Wiley Zanthia, Principal Investigator
Nadine Rouphael, Sub-Investigator
Cassie Grimsley-Ackerley, Sub-Investigator
Kristen Unterberger, Sub-Investigator
Veronica Smith, Sub-Investigator
Mary Atha, Sub-Investigator
Paulina Rebolledo Esteinou, Sub-Investigator
Kelley Colleen, Sub-Investigator
Srilatha Edupuganti, Sub-Investigator
Matthew Collins, Sub-Investigator
Zanthia Wiley, Sub-Investigator
Daniel Graciaa, Sub-Investigator
Jessica Traenkner, Sub-Investigator
Recruiting
Illinois
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States
Phyllis Zee, MD, Contact
Phyllis Zee, Principal Investigator
Kathryn Reid, Sub-Investigator
Paul Chung, Sub-Investigator
Alexander Choi, Sub-Investigator
Lisa Wolfe, Sub-Investigator
Sabra Abbott, Sub-Investigator
Mathew Mass, Sub-Investigator
Recruiting
Cook County Health Specialty Care Center, Chicago, Illinois, 60612, United States
Active, not recruiting
Rush University Medical Center, Chicago, Illinois, 60612, United States
James Moy, MD, Contact
James Moy, MD, Principal Investigator
Babak Mokhlesi, MD, Sub-Investigator
Recruiting
University of Illinois at Chicago, Chicago, Illinois, 60612, United States
Bharati Prasad, MD, Contact
Bharati Prasad, MD, Principal Investigator
Recruiting
NorthShore Medical Group, Evanston, Illinois, 60201, United States
Mary Ellen Acree, MD, Contact, [email protected]
Amanda Caplan, MD, Contact, 1-224-364-2273, [email protected]
Mary Ellen Acree, MD, Principal Investigator
Oluwadamilola Adeyemi, MD, Sub-Investigator
Amanda Caplan, MD, Sub-Investigator
Michael Glickman, MD, Sub-Investigator
Benjamin Margolis, MD, Sub-Investigator
Nicholas Mathenia, MD, Sub-Investigator
Recruiting
Saint Francis Medical Center, Peoria, Illinois, 61606, United States
Patrick Whitten, MD, Contact
Patrick Whitten, Principal Investigator
Ossama Ikladios, Sub-Investigator
Subramanyam Chittivelu, Sub-Investigator
Kaninika Verma, Sub-Investigator
Recruiting
Kansas
University of Kansas Medical Center, Kansas City, Kansas, 66160, United States
Damien Stevens, MD, Contact
Damien Stevens, Principal Investigator
Diego Mazzotti, Sub-Investigator
Recruiting
Kentucky
University of Kentucky, Lexington, Kentucky, 40536, United States
Christopher Simmons, MD, Contact
Christopher Simmons, MD, Principal Investigator
Robert Murray, Sub-Investigator
Sara Pasha, Sub-Investigator
Sidney Whiteheart, Sub-Investigator
Recruiting
Maryland
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, 21224, United States
Jonathan Jun, MD, Contact, 410-550-0115, [email protected]
Jonathan Jun, MD, Principal Investigator
Daisy Duan, MD, Sub-Investigator
Luu Pham, MD, Sub-Investigator
Recruiting
Jadestone Clinical Research, LLC, Silver Spring, Maryland, 20904, United States
Jonathan Cohen, MD, Contact
Jonathan Cohen, Principal Investigator
Homam Ibrahim, Sub-Investigator
Recruiting
Massachusetts
Tufts Medical Center, Boston, Massachusetts, 02111, United States
Aarti Grover, MD, Contact, 617-636-7689, [email protected]
Aarti Grover, MD, Principal Investigator
Recruiting
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Aleksandar Videnovic, MD, Contact, 671-724-3837, [email protected]
Aleksandar Videnovic, MD, Principal Investigator
Recruiting
Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States
Daniel Gottlieb, MD, Contact
Daniel Gottlieb, MD, Principal Investigator
Susan Redline, MD, Sub-Investigator
Recruiting
Boston Medical Center, Boston, Massachusetts, 02118, United States
Sanford Auerbach, MD, Contact
Sanford Auerbach, Principal Investigator
Steven Lenio, Sub-Investigator
Recruiting
Beth Israel Deaconess Med. Ctr., Boston, Massachusetts, 02215, United States
Janet Mullington, MD, Contact
Janet Mullington, Principal Investigator
Robert Thomas, Sub-Investigator
Recruiting
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, 01655, United States
Jennifer Wang, MD, Contact
Jennifer Wang, MD, Principal Investigator
Evan Bradley, Sub-Investigator
Mary Co, Sub-Investigator
Recruiting
New Jersey
Rutgers University - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08901, United States
Sabiha Hussain, MD, Contact
Sabiha Hussain, Principal Investigator
Aesha Jobanputra, Sub-Investigator
Recruiting
New Mexico
University of New Mexico, Albuquerque, New Mexico, 87102, United States
Shanna Diaz, MD, Contact, 505-272-2515, [email protected]
Shanna Diaz, MD, Principal Investigator
Recruiting
New York
Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States
Vaishnavi Kundel, MD, Contact
Vaishnavi Kundel, MD, Principal Investigator
Mira Tadros, Sub-Investigator
Recruiting
North Carolina
East Carolina University, Greenville, North Carolina, 27834, United States
Paul Bolin, MD, Contact
Paul Bolin, MD, Principal Investigator
Recruiting
Ohio
University of Cincinnati Medical Center, Cincinnati, Ohio, 45220, United States
Ann Romaker, MD, Contact
Ann Romaker, MD, Principal Investigator
Rachel Foot, MD, Sub-Investigator
Recruiting
University Hospitals of Cleveland Medical Center, Cleveland, Ohio, 44106, United States
Kingman Strohl, MD, Contact
Kingman Strohl, MD, Principal Investigator
Susheel Patil, Sub-Investigator
Recruiting
Oregon
Oregon Health and Science University, Portland, Oregon, 97239, United States
Hope Aluko, MD, Contact
Hope Aluko, Principal Investigator
Akram Khan, Sub-Investigator
Maureen Lyons, Sub-Investigator
Recruiting
Texas
Southwest Family Medicine Associates, Dallas, Texas, 75235, United States
Chrisette Sharma, MD, Contact, 469-893-1242, [email protected]
Chrisette Dharma, MD, Principal Investigator
Angela Kemp, MD, Sub-Investigator
Monica Ramirez, MD, Sub-Investigator
Recruiting
Houston Methodist Hospital, Houston, Texas, 77030, United States
Eleftherios Mylonakis, MD, Contact
Eleftherios Mylonakis, Principal Investigator
Rodney Folz, Sub-Investigator
Deepa Gotur, Sub-Investigator
Faisal Zahiruddin, Sub-Investigator
Recruiting
University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States
Reeba Matthew, MD, Contact
Reeba Matthew, MD, Principal Investigator
Bela Patel, Sub-Investigator
Ruckshanda Majid, Sub-Investigator
Recruiting
New Dawn Wellness and Medical Research Center, Houston, Texas, 77082, United States
Adanna Ukazu, MD, Contact
Adanna Ukazu, MD, Principal Investigator
Kerollos Shaker, MD, Sub-Investigator
Elaine Shehata, MD, Sub-Investigator
Recruiting
Virginia
University of Virginia Health System, Charlottesville, Virginia, 22908, United States
Alexandra Kadl, MD, Contact
Alexandra Kadl, MD, Principal Investigator
Scott Schecter, MD, Sub-Investigator
Jeffrey Sturek, MD.PhD, Sub-Investigator
Recruiting
Washington
Evergreen Hospital Medical Center, Kirkland, Washington, 98034, United States
Pinky Agarwal, MD, Contact
Pinky Agarwal, MD, Principal Investigator
Recruiting
West Virginia
University Physicians and Surgeons (DBA Marshall Health), Huntington, West Virginia, 25701, United States
Imran Khawaja, MD, Contact
Imran Khawaja, MD, Principal Investigator
Recruiting
West Virginia Clinical and Translational Science Institute, Morgantown, West Virginia, 26506, United States
Sunil Sharma, MD, Contact
Sunil Sharma, Principal Investigator
Robert Stansbury, Sub-Investigator
Edward Rojas, Sub-Investigator
Recruiting
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Rose Franco, MD, Contact, 414-955-7040, [email protected]
Rose Franco, MD, Principal Investigator
Recruiting