Phase
Condition
Sleep Disorders
Restless Leg Syndrome
Insomnia
Treatment
Tailored lighting (TL) Active
Solriamfetol Placebo
Solriamfetol
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
The Southern Arizona VA Health Care System
Tucson, Arizona 85723
United StatesSite Not Available
University of Arizona Banner Medical Center
Tucson, Arizona 85719
United StatesActive - Recruiting
Banner University Medical Center Phoenix
Phoenix 5308655, Arizona 5551752 85006
United StatesSite Not Available
The Southern Arizona VA Health Care System
Tucson 5318313, Arizona 5551752 85723
United StatesSite Not Available
University of Arizona Banner Medical Center
Tucson 5318313, Arizona 5551752 85719
United StatesSite Not Available
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
University of California San Francisco General Hospital
San Francisco, California 94143
United StatesSite Not Available
Stanford University
Stanford, California 94305
United StatesSite Not Available
Stanford University
Palo Alto 5380748, California 5332921 94304
United StatesSite Not Available
University of California San Francisco General Hospital
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
Denver Health and Hospital Authority
Denver, Colorado 80204
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Denver Health and Hospital Authority
Denver 5419384, Colorado 5417618 80204
United StatesSite Not Available
Howard University Hospital
Washington, District of Columbia 20060
United StatesSite Not Available
Howard University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20060
United StatesSite Not Available
University of Florida College of Medicine Jacksonville
Jacksonville, Florida 32209
United StatesSite Not Available
Lakeland Regional Medical Center
Lakeland, Florida 33805
United StatesSite Not Available
University of Florida College of Medicine Jacksonville
Jacksonville 4160021, Florida 4155751 32209
United StatesSite Not Available
Lakeland Regional Medical Center
Lakeland 4161438, Florida 4155751 33805
United StatesSite Not Available
Atlanta VA Medical Center
Atlanta, Georgia 30033
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Grady Memorial Hospital
Atlanta, Georgia 30303
United StatesActive - Recruiting
Morehouse School of Medicine
Atlanta, Georgia 30310
United StatesActive - Recruiting
Atlanta VA Medical Center
Decatur, Georgia 30030
United StatesSite Not Available
Emory Hope Clinic
Decatur, Georgia 30030
United StatesActive - Recruiting
Emory University
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Grady Memorial Hospital
Atlanta 4180439, Georgia 4197000 30303
United StatesSite Not Available
Morehouse School of Medicine
Atlanta 4180439, Georgia 4197000 30310
United StatesSite Not Available
Atlanta VA Medical Center
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
Emory Hope Clinic
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
Cook County Health Specialty Care Center
Chicago, Illinois 60612
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois at Chicago
Chicago, Illinois 60612
United StatesActive - Recruiting
NorthShore Medical Group
Evanston, Illinois 60201
United StatesSite Not Available
Saint Francis Medical Center
Peoria, Illinois 61606
United StatesSite Not Available
Cook County Health Specialty Care Center
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
NorthShore Medical Group
Evanston 4891382, Illinois 4896861 60201
United StatesSite Not Available
Saint Francis Medical Center
Peoria 4905687, Illinois 4896861 61606
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
University of Kentucky
Lexington 4297983, Kentucky 6254925 40536
United StatesSite Not Available
Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224
United StatesSite Not Available
Jadestone Clinical Research, LLC
Silver Spring, Maryland 20904
United StatesSite Not Available
Johns Hopkins Bayview Medical Center
Baltimore 4347778, Maryland 4361885 21224
United StatesSite Not Available
Jadestone Clinical Research, LLC
Silver Spring 4369596, Maryland 4361885 20904
United StatesSite Not Available
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 StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesActive - Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United StatesSite Not Available
Beth Israel Deaconess Med. Ctr.
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
United StatesSite Not Available
Brigham and Womens Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
United StatesSite Not Available
University of Massachusetts Memorial Medical Center
Worcester 4956184, Massachusetts 6254926 01655
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
United StatesSite Not Available
Rutgers University - Robert Wood Johnson Medical School
New Brunswick 5101717, New Jersey 5101760 08901
United StatesSite Not Available
University of New Mexico
Albuquerque, New Mexico 87102
United StatesSite Not Available
University of New Mexico
Albuquerque 5454711, New Mexico 5481136 87102
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesSite Not Available
East Carolina University
Greenville, North Carolina 27834
United StatesSite Not Available
East Carolina University
Greenville 4469160, North Carolina 4482348 27834
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45220
United StatesSite Not Available
University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45220
United StatesSite Not Available
University Hospitals of Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Southwest Family Medicine Associates
Dallas, Texas 75235
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
New Dawn Wellness and Medical Research Center
Houston, Texas 77082
United StatesSite Not Available
University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesActive - Recruiting
Southwest Family Medicine Associates
Dallas 4684888, Texas 4736286 75235
United StatesSite Not Available
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
New Dawn Wellness and Medical Research Center
Houston 4699066, Texas 4736286 77082
United StatesSite Not Available
University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesSite Not Available
University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 22908
United StatesSite Not Available
Evergreen Hospital Medical Center
Kirkland, Washington 98034
United StatesSite Not Available
Evergreen Hospital Medical Center
Kirkland 5799841, Washington 5815135 98034
United StatesSite Not Available
University Physicians and Surgeons (DBA Marshall Health)
Huntington, West Virginia 25701
United StatesSite Not Available
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia 26506
United StatesSite Not Available
University Physicians and Surgeons (DBA Marshall Health)
Huntington 4809537, West Virginia 4826850 25701
United StatesSite Not Available
West Virginia Clinical and Translational Science Institute
Morgantown 4815352, West Virginia 4826850 26506
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

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