Phase
Condition
Sleep Disorders
Insomnia
Restless Leg Syndrome
Treatment
Solriamfetol
Melatonin
Modafinil Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 thePan 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) 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;
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.
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
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.
Willing and able to provide informed consent, complete the surveys and clinicalassessments, and return for all of the necessary follow-up visits
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:
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 bipolardisorder
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*
Known allergy/sensitivity or any hypersensitivity to components of the studyintervention or control*
Known contraindication(s) to study intervention including prohibited concomitantmedications and without the ability to safely hold prohibited concomitantmedications (see appendices)*
Currently receiving/using intervention from another clinical trial that could impactor 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.
Study Design
Study Description
Connect with a study center
Banner University Medical Center Phoenix
Phoenix, Arizona 85006
United StatesSite Not Available
University of Arizona Banner Medical Center
Tucson, Arizona 85719
United StatesActive - Recruiting
University of California San Francisco General Hospital
San Francisco, California 94143
United StatesActive - Recruiting
Stanford University
Stanford, California 94305
United StatesActive - Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
Denver Health and Hospital Authority
Denver, Colorado 80204
United StatesActive - Recruiting
Howard University Hospital
Washington, District of Columbia 20060
United StatesActive - Recruiting
University of Florida College of Medicine Jacksonville
Jacksonville, Florida 32209
United StatesActive - Recruiting
Atlanta VA Medical Center
Atlanta, Georgia 30033
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Grady Memorial Hospital
Atlanta, Georgia 30303
United StatesActive - Recruiting
Morehouse School of Medicine
Atlanta, Georgia 30310
United StatesActive - Recruiting
Emory Hope Clinic
Decatur, Georgia 30030
United StatesActive - Recruiting
Cook County Health Specialty Care Center
Chicago, Illinois 60612
United StatesActive - Recruiting
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesActive - Recruiting
University of Illinois at Chicago
Chicago, Illinois 60612
United StatesActive - Recruiting
NorthShore Medical Group
Evanston, Illinois 60201
United StatesActive - Recruiting
Saint Francis Medical Center
Peoria, Illinois 61606
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Kentucky
Lexington, Kentucky 40536
United StatesActive - Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224
United StatesActive - Recruiting
Jadestone Clinical Research, LLC
Silver Spring, Maryland 20904
United StatesActive - Recruiting
Beth Israel Deaconess Med. Ctr.
Boston, Massachusetts 02215
United StatesActive - Recruiting
Boston Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Brigham and Womens Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Tufts Medical Center
Boston, Massachusetts 02111
United StatesActive - Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
University of New Mexico
Albuquerque, New Mexico 87106
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
East Carolina University
Greenville, North Carolina 27834
United StatesActive - Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio 45220
United StatesActive - Recruiting
University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
Southwest Family Medicine Associates
Dallas, Texas 75235
United StatesActive - Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
New Dawn Wellness and Medical Research Center
Houston, Texas 77082
United StatesActive - Recruiting
University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesActive - Recruiting
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesActive - Recruiting
University Physicians and Surgeons (DBA Marshall Health)
Huntington, West Virginia 25701
United StatesActive - Recruiting
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia 26506
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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