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Université DukeRECOVER-SLEEP: Platform Protocol
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L'essai clinique NCT06404086 est conçu pour étudier le treatment de COVID long, COVID-19 long, Hypersomnie, Perturbation du sommeil. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : en recrutement. L'essai a débuté le 31 juillet 2024 et vise à recruter 1 074 participants. Dirigé par l'Université Duke, l'essai devrait être terminé d'ici le 31 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 19 août 2025.
Résumé succinct
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).
Description détaillée
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.
Titre officiel
RECOVER-SLEEP: A Platform Protocol for Evaluation of Interventions for Sleep Disturbances in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Conditions
COVID longCOVID-19 longHypersomniePerturbation du sommeilAutres identifiants de l'essai
- Pro00112484
- OTA-21-015G (Autre financement) (NIH Grant to RTI; RTI subcontracting with DCRI)
Numéro NCT
Date de début (réel)
2024-07-31
Dernière mise à jour publiée
2025-08-19
Date de fin (estimée)
2025-12-31
Inscription (estimée)
1 074
Type d'essai
Interventionnel
PHASE
Phase II
Statut
En recrutement
Mots clés
PASC
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Triple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
AutreHypersomnia 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. |
AutreComplex 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. | Mélatonine 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. |
Critère principal d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
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.
Université Duke545 essais cliniques actifs à explorerContact central de l'essai
Contact: Jaelyn R Linski, BA, CCRC, 919-668-8060, [email protected]
Contact: Barrie L Harper, BSMT (ASCP) PMP, [email protected]
47 Centres de l'essai dans 1 pays
Arizona
Banner University Medical Center Phoenix, Phoenix, Arizona, 85006, United States
Actif, pas en recrutement
University of Arizona Banner Medical Center, Tucson, Arizona, 85719, United States
Heidi Erickson, Contact, 520-626-5287, [email protected]
Parthasarathy Sairam, MD, Investigateur principal
En recrutement
The Southern Arizona VA Health Care System, Tucson, Arizona, 85723, United States
Adnan Abbasi, MD, Contact
Adnan Abbasi, Investigateur principal
En recrutement
California
Stanford University, Palo Alto, California, 94304, United States
Clete Kushida, MD, Contact, 650-723-6601, [email protected]
Clete Kushida, MD, Investigateur principal
En recrutement
University of California San Francisco General Hospital, San Francisco, California, 94143, United States
Aric Prather, MD, Contact
Aric Prather, Investigateur principal
Andrew Krystal, Investigateur associé
En recrutement
Colorado
University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States
Sarah Jolley, MD, Contact
Sarah Jolley, MD, Investigateur principal
Kristine Erlandson, Investigateur associé
Neale Lange, Investigateur associé
En recrutement
Denver Health and Hospital Authority, Denver, Colorado, 80204, United States
Edward Gardner, MD, Contact
Edward Gardner, Investigateur principal
En recrutement
District of Columbia
Howard University Hospital, Washington D.C., District of Columbia, 20060, United States
Peter Whitesell, Contact
Peter Whitesell, MD, Investigateur principal
Zara Martirosyan, Investigateur associé
Alem Mehari, Investigateur associé
En recrutement
Florida
University of Florida College of Medicine Jacksonville, Jacksonville, Florida, 32209, United States
Carmen Isache, MD, Contact
Carmen Isache, MD, Investigateur principal
Jorge Verdecia, MD, Investigateur associé
En recrutement
Lakeland Regional Medical Center, Lakeland, Florida, 33805, United States
Debra Seoane, MD, Contact
Debra Seoane, MD, Investigateur principal
En recrutement
Georgia
Grady Memorial Hospital, Atlanta, Georgia, 30303, United States
Jenny Han, MD, Contact
Jenny Han, Investigateur principal
Tiffany Walker, Investigateur associé
En recrutement
Morehouse School of Medicine, Atlanta, Georgia, 30310, United States
Priscilla Igho-Pemu, Contact
Priscilla Igho-Pemu, Investigateur principal
En recrutement
Emory University, Atlanta, Georgia, 30322, United States
Dayna Johnson, MD, Contact, 404-727-8708, [email protected]
Dayna Johnson, MD, Investigateur principal
Nancy Collop, MD, Investigateur associé
Alex Truong, MD, Investigateur associé
En recrutement
Atlanta VA Medical Center, Decatur, Georgia, 30030, United States
Barry Fields, MD, Contact
Barry Fields, MD, Investigateur principal
En recrutement
Emory Hope Clinic, Decatur, Georgia, 30030, United States
Wiley Zanthia, MD, Contact
Wiley Zanthia, Investigateur principal
Nadine Rouphael, Investigateur associé
Cassie Grimsley-Ackerley, Investigateur associé
Kristen Unterberger, Investigateur associé
Veronica Smith, Investigateur associé
Mary Atha, Investigateur associé
Paulina Rebolledo Esteinou, Investigateur associé
Kelley Colleen, Investigateur associé
Srilatha Edupuganti, Investigateur associé
Matthew Collins, Investigateur associé
Zanthia Wiley, Investigateur associé
Daniel Graciaa, Investigateur associé
Jessica Traenkner, Investigateur associé
En recrutement
Illinois
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States
Phyllis Zee, MD, Contact
Phyllis Zee, Investigateur principal
Kathryn Reid, Investigateur associé
Paul Chung, Investigateur associé
Alexander Choi, Investigateur associé
Lisa Wolfe, Investigateur associé
Sabra Abbott, Investigateur associé
Mathew Mass, Investigateur associé
En recrutement
Cook County Health Specialty Care Center, Chicago, Illinois, 60612, United States
Actif, pas en recrutement
Rush University Medical Center, Chicago, Illinois, 60612, United States
James Moy, MD, Contact
James Moy, MD, Investigateur principal
Babak Mokhlesi, MD, Investigateur associé
En recrutement
University of Illinois at Chicago, Chicago, Illinois, 60612, United States
Bharati Prasad, MD, Contact
Bharati Prasad, MD, Investigateur principal
En recrutement
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, Investigateur principal
Oluwadamilola Adeyemi, MD, Investigateur associé
Amanda Caplan, MD, Investigateur associé
Michael Glickman, MD, Investigateur associé
Benjamin Margolis, MD, Investigateur associé
Nicholas Mathenia, MD, Investigateur associé
En recrutement
Saint Francis Medical Center, Peoria, Illinois, 61606, United States
Patrick Whitten, MD, Contact
Patrick Whitten, Investigateur principal
Ossama Ikladios, Investigateur associé
Subramanyam Chittivelu, Investigateur associé
Kaninika Verma, Investigateur associé
En recrutement
Kansas
University of Kansas Medical Center, Kansas City, Kansas, 66160, United States
Damien Stevens, MD, Contact
Damien Stevens, Investigateur principal
Diego Mazzotti, Investigateur associé
En recrutement
Kentucky
University of Kentucky, Lexington, Kentucky, 40536, United States
Christopher Simmons, MD, Contact
Christopher Simmons, MD, Investigateur principal
Robert Murray, Investigateur associé
Sara Pasha, Investigateur associé
Sidney Whiteheart, Investigateur associé
En recrutement
Maryland
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, 21224, United States
Jonathan Jun, MD, Contact, 410-550-0115, [email protected]
Jonathan Jun, MD, Investigateur principal
Daisy Duan, MD, Investigateur associé
Luu Pham, MD, Investigateur associé
En recrutement
Jadestone Clinical Research, LLC, Silver Spring, Maryland, 20904, United States
Jonathan Cohen, MD, Contact
Jonathan Cohen, Investigateur principal
Homam Ibrahim, Investigateur associé
En recrutement
Massachusetts
Tufts Medical Center, Boston, Massachusetts, 02111, United States
Aarti Grover, MD, Contact, 617-636-7689, [email protected]
Aarti Grover, MD, Investigateur principal
En recrutement
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Aleksandar Videnovic, MD, Contact, 671-724-3837, [email protected]
Aleksandar Videnovic, MD, Investigateur principal
En recrutement
Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States
Daniel Gottlieb, MD, Contact
Daniel Gottlieb, MD, Investigateur principal
Susan Redline, MD, Investigateur associé
En recrutement
Boston Medical Center, Boston, Massachusetts, 02118, United States
Sanford Auerbach, MD, Contact
Sanford Auerbach, Investigateur principal
Steven Lenio, Investigateur associé
En recrutement
Beth Israel Deaconess Med. Ctr., Boston, Massachusetts, 02215, United States
Janet Mullington, MD, Contact
Janet Mullington, Investigateur principal
Robert Thomas, Investigateur associé
En recrutement
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, 01655, United States
Jennifer Wang, MD, Contact
Jennifer Wang, MD, Investigateur principal
Evan Bradley, Investigateur associé
Mary Co, Investigateur associé
En recrutement
New Jersey
Rutgers University - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08901, United States
Sabiha Hussain, MD, Contact
Sabiha Hussain, Investigateur principal
Aesha Jobanputra, Investigateur associé
En recrutement
New Mexico
University of New Mexico, Albuquerque, New Mexico, 87102, United States
Shanna Diaz, MD, Contact, 505-272-2515, [email protected]
Shanna Diaz, MD, Investigateur principal
En recrutement
New York
Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States
Vaishnavi Kundel, MD, Contact
Vaishnavi Kundel, MD, Investigateur principal
Mira Tadros, Investigateur associé
En recrutement
North Carolina
East Carolina University, Greenville, North Carolina, 27834, United States
Paul Bolin, MD, Contact
Paul Bolin, MD, Investigateur principal
En recrutement
Ohio
University of Cincinnati Medical Center, Cincinnati, Ohio, 45220, United States
Ann Romaker, MD, Contact
Ann Romaker, MD, Investigateur principal
Rachel Foot, MD, Investigateur associé
En recrutement
University Hospitals of Cleveland Medical Center, Cleveland, Ohio, 44106, United States
Kingman Strohl, MD, Contact
Kingman Strohl, MD, Investigateur principal
Susheel Patil, Investigateur associé
En recrutement
Oregon
Oregon Health and Science University, Portland, Oregon, 97239, United States
Hope Aluko, MD, Contact
Hope Aluko, Investigateur principal
Akram Khan, Investigateur associé
Maureen Lyons, Investigateur associé
En recrutement
Texas
Southwest Family Medicine Associates, Dallas, Texas, 75235, United States
Chrisette Sharma, MD, Contact, 469-893-1242, [email protected]
Chrisette Dharma, MD, Investigateur principal
Angela Kemp, MD, Investigateur associé
Monica Ramirez, MD, Investigateur associé
En recrutement
Houston Methodist Hospital, Houston, Texas, 77030, United States
Eleftherios Mylonakis, MD, Contact
Eleftherios Mylonakis, Investigateur principal
Rodney Folz, Investigateur associé
Deepa Gotur, Investigateur associé
Faisal Zahiruddin, Investigateur associé
En recrutement
University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States
Reeba Matthew, MD, Contact
Reeba Matthew, MD, Investigateur principal
Bela Patel, Investigateur associé
Ruckshanda Majid, Investigateur associé
En recrutement
New Dawn Wellness and Medical Research Center, Houston, Texas, 77082, United States
Adanna Ukazu, MD, Contact
Adanna Ukazu, MD, Investigateur principal
Kerollos Shaker, MD, Investigateur associé
Elaine Shehata, MD, Investigateur associé
En recrutement
Virginia
University of Virginia Health System, Charlottesville, Virginia, 22908, United States
Alexandra Kadl, MD, Contact
Alexandra Kadl, MD, Investigateur principal
Scott Schecter, MD, Investigateur associé
Jeffrey Sturek, MD.PhD, Investigateur associé
En recrutement
Washington
Evergreen Hospital Medical Center, Kirkland, Washington, 98034, United States
Pinky Agarwal, MD, Contact
Pinky Agarwal, MD, Investigateur principal
En recrutement
West Virginia
University Physicians and Surgeons (DBA Marshall Health), Huntington, West Virginia, 25701, United States
Imran Khawaja, MD, Contact
Imran Khawaja, MD, Investigateur principal
En recrutement
West Virginia Clinical and Translational Science Institute, Morgantown, West Virginia, 26506, United States
Sunil Sharma, MD, Contact
Sunil Sharma, Investigateur principal
Robert Stansbury, Investigateur associé
Edward Rojas, Investigateur associé
En recrutement
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Rose Franco, MD, Contact, 414-955-7040, [email protected]
Rose Franco, MD, Investigateur principal
En recrutement