Sleep for Stroke Management and Recovery Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Michigan
Study ID
NCT03812653
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CPAP — DEVICE
    Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.

Study Details

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Key Dates

First listed
Jan 23, 2019
Start date
May 9, 2019
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
3,062 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Arm: CPAP with Usual Care.
    6 months of CPAP plus usual medical therapy.
  • No Intervention: Control Arm: Usual Care.
    6 months of usual medical therapy alone.

Primary Outcome Measure

Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality [ Time Frame: 6 months post randomization ]

Locations (116)

FacilityCityStateZIPSite coordinators
University of Alabama HospitalBirminghamAlabama35294-
Chandler Regional Medical CenterChandlerArizona85224-
Banner University Medical Center PhoenixPhoenixArizona85006-
Dignity Health - St. Joseph's Hospital and Medical CenterPhoenixArizona85013-
Banner- University Medical Center TucsonTucsonArizona85719-
TMC HealthcareTucsonArizona85712-
Mercy San Juan Medical CenterCarmichaelCalifornia95608-
Rancho Los Amigos National Rehabilitation CenterDowneyCalifornia90242-
Scripps MemorialLa JollaCalifornia92037-
UCSD Health La JollaLa JollaCalifornia92103-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Kaiser Permanente Los AngelesLos AngelesCalifornia94612-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
Doctors Medical Center of ModestoModestoCalifornia95355-
UCLA Kaiser FontanaOntarioCalifornia91761-
UC IrvineOrangeCalifornia92868-
Casa ColinaPomonaCalifornia91767-
Kaiser RedwoodRedwood CityCalifornia94063-
UC Davis Medical CenterSacramentoCalifornia95817-
UCSD Medical Center - Hillcrest HospitalSan DiegoCalifornia92103-
UCSF Helen Diller Medical Center at Parnassus HeightsSan FranciscoCalifornia94143-
Orange County Global Medical CenterSanta AnaCalifornia92705-
Olive View- UCLA Medical CenterSylmarCalifornia91342-
John Muir Medical Center- Walnut Creek CampusWalnut CreekCalifornia94598-
St. Mary's Hospital and Medical CenterGrand JunctionColorado81501-
Hartford HospitalHartfordConnecticut06102-
Yale-New Haven HospitalNew HavenConnecticut06510-
George Washington University HospitalWashington D.C.District of Columbia20037-
Morton Plant HospitalClearwaterFlorida33756-
Broward HealthFort LauderdaleFlorida33305-
UF Health Shands HospitalGainesvilleFlorida32611-
Brooks Rehabilitation HospitalJacksonvilleFlorida32216-
UF JacksonvilleJacksonvilleFlorida32209-
Baptist Hospital of MiamiMiamiFlorida33176-
Jackson Memorial HospitalMiamiFlorida33136-
Sarasota Memorial HospitalSarasotaFlorida34239-
St. Joseph's HospitalTampaFlorida33607-
Tampa General HospitalTampaFlorida33606-
Grady Memorial HospitalAtlantaGeorgia30303-
Rush University Medical CenterChicagoIllinois60612-
University of ChicagoChicagoIllinois60637-
University of Illinois Hospital and Health Sciences SystemChicagoIllinois60612-
OSF Saint Francis Medical CenterPeoriaIllinois61603-
Memorial Medical CenterSpringfieldIllinois62702-
Iowa MethodistDes MoinesIowa50309-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Norton HealthCareLouisvilleKentucky40218-
Ochsner Medical Center - Main CampusNew OrleansLouisiana70121-
University Health ShreveportShreveportLouisiana71103-
University of MarylandBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
UMass Memorial Medical Center,WorcesterMassachusetts01655-
Henry Ford HospitalDetroitMichigan48202-
McLaren FlintFlintMichigan48532-
Trinity Health Saint Mary'sGrand RapidsMichigan49503-
Bronson Methodist HospitalKalamazooMichigan49008-
Mayo Clinic Saint Marys CampusRochesterMinnesota55905-
Saint Cloud/Centracare HealthSaint CloudMinnesota56303-
University of Mississippi Medical CenterJacksonMississippi39216-
Saint Luke's Hospital of Kansas CityKansas CityMissouri64111-
Cox Medical CenterSpringfieldMissouri65807-
Barnes-Jewish HospitalSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-
JFK Neuroscience InstituteEdisonNew Jersey08820-
Cooperman Barnabas Medical CenterLivingstonNew Jersey07039-
Hackensack Meridian Jersey Shore University Medical CenterNeptune CityNew Jersey07753-
University of New Mexico HospitalAlbuquerqueNew Mexico87106-
Maimonides Medical CenterBrooklynNew York11219-
NYU Langone BrooklynBrooklynNew York11220-
Buffalo General Medical CenterBuffaloNew York14203-
North Shore University HospitalManhassetNew York11030-
Bellevue HospitalNew YorkNew York10016-
NYP Columbia University Medical CenterNew YorkNew York10032-
NYU Langone -Tish Hospital Medical CenterNew YorkNew York10016-
Strong Memorial HospitalRochesterNew York14642-
Staten Island University HospitalStaten IslandNew York10305-
Suny Upstate Medical UniversitySyracuseNew York13210-
Montefiore Medical CenterThe BronxNew York10467-
Carolinas Medical Center Atrium HealthCharlotteNorth Carolina28203-
Carolinas Rehab NortheastConcordNorth Carolina28025-
Guilford Neurologic Associates, IncGreensboroNorth Carolina27401-
Wake Forest University Baptist Medical CenterWinston-SalemNorth Carolina27157-
Christ HospitalCincinnatiOhio45219-
University of Cincinnati Medical CenterCincinnatiOhio45219-
Cleveland ClinicClevelandOhio44195-
UH Cleveland Medical CenterClevelandOhio11100-
OSU Wexner Medical CenterColumbusOhio43210-
West Chester HospitalWest ChesterOhio45069-
St. John Health SystemTulsaOklahoma74104-
Providence St. Vincent Medical CenterPortlandOregon97225-
St. Luke's University Hospital Bethlehem CampusBethlehemPennsylvania18015-
Geisinger ClinicDanvillePennsylvania17822-
Penn State Milton S. Hershey CenterHersheyPennsylvania17033-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Temple University HospitalPhiladelphiaPennsylvania19122-
UPMC Presbyterian HospitalPittsburghPennsylvania15213-
Palmetto Health RichlandColumbiaSouth Carolina29203-
Greenville Memorial HospitalGreenvilleSouth Carolina29605-
Avera Research InstituteSioux FallsSouth Dakota57108-
Fort Sanders Regional Medical CenterKnoxvilleTennessee37916-
Methodist UniversityMemphisTennessee38105-
Baylor Scott & White Institute of RehabilitationDallasTexas75246-
Memorial Hermann Texas Medical CenterHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84107-
University of Utah HealthcareSalt Lake CityUtah84132-
The University of Vermont Medical Center Main CampusBurlingtonVermont05401-
UVA Medical CenterCharlottesvilleVirginia22908-
Inova FairfaxFalls ChurchVirginia22042-
Virginia Commonwealth UniversityRichmondVirginia23219-
Harborview Medical CenterSeattleWashington98195-
Virginia Mason Medical CenterSeattleWashington98101-
Ruby Memorial HospitalMorgantownWest Virginia26506-
Gundersen Lutheran Medical FoundationLa CrosseWisconsin54601-
University of Wisconsin University HospitalMadisonWisconsin53715-

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