Clinical trial NCT03812653: Sleep for Stroke Management and Recovery Trial
Official title: Sleep for Stroke Management and Recovery Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
Stroke
CPAP
Telemedicine
Home Sleep Apnea Test
Randomized Clinical Trial
Multicenter Trial
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: FusionHealth LLC
name: Medical University of South Carolina
name: University of Cincinnati
First posted: 2019-01-23
Enrollment: 3062
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network.

Eligibility criteria: Current Inclusion Criteria, as of 6/28/2024:

1. Ischemic stroke within the prior 7 days.
2. NIH Stroke Scale Score ≥1 at the time of enrollment

Previous Inclusion Criteria, prior to 6/28/2024:

1. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days.

Exclusion Criteria (for entire time period):

1. pre-event inability to perform all of own basic ADLs
2. unable to obtain informed consent from subject or legally authorized representative
3. incarcerated
4. known pregnancy
5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy
6. current use of positive airway pressure, or use within one month prior to stroke
7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
8. severe bullous lung disease
9. history of prior spontaneous pneumothorax or current pneumothorax
10. hypotension requiring current treatment with pressors (can enroll later if this resolves)
11. other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
12. massive epistaxis or previous history of massive epistaxis
13. cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
14. recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure
15. current receipt of oxygen supplementation \>4 liters per minute
16. current contact, droplet, respiratory/airborne precautions

Primary outcomes:
measure: Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
timeFrame: 6 months post randomization
measure: Modified Rankin Scale Score
timeFrame: 3 months post randomization
Secondary outcomes:
measure: NIH Stroke Score (NIHSS)
timeFrame: 3 months post randomization
measure: Short Montreal Cognitive Assessment (MoCA) Score
timeFrame: 3 months post randomization
measure: Quality of Life outcome
timeFrame: 3 months post randomization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
city: Phoenix
country: United States
facility: Dignity Health - St. Joseph's Hospital and Medical Center
state: Arizona
city: Tucson
country: United States
facility: TMC Healthcare
state: Arizona
city: Tucson
country: United States
facility: Banner- University Medical Center Tucson
state: Arizona
city: Carmichael
country: United States
facility: Mercy San Juan Medical Center
state: California
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: La Jolla
country: United States
facility: Scripps Memorial
state: California
city: La Jolla
country: United States
facility: UCSD Health La Jolla
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles
state: California
city: Modesto
country: United States
facility: Doctors Medical Center of Modesto
state: California
city: Ontario
country: United States
facility: UCLA Kaiser Fontana
state: California
city: Orange
country: United States
facility: UC Irvine
state: California
city: Pomona
country: United States
facility: Casa Colina
state: California
city: Redwood City
country: United States
facility: Kaiser Redwood
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center - Hillcrest Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Medical Center at Parnassus Heights
state: California
city: Santa Ana
country: United States
facility: Orange County Global Medical Center
state: California
city: Sylmar
country: United States
facility: Olive View- UCLA Medical Center
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center- Walnut Creek Campus
state: California
city: Grand Junction
country: United States
facility: St. Mary's Hospital and Medical Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Health
state: Florida
city: Gainesville
country: United States
facility: UF Health Shands Hospital
state: Florida
city: Jacksonville
country: United States
facility: UF Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Brooks Rehabilitation Hospital
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Des Moines
country: United States
facility: Iowa Methodist
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: Norton HealthCare
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center - Main Campus
state: Louisiana
city: Shreveport
country: United States
facility: University Health Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center,
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Flint
country: United States
facility: McLaren Flint
state: Michigan
city: Grand Rapids
country: United States
facility: Trinity Health Saint Mary's
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Saint Marys Campus
state: Minnesota
city: Saint Cloud
country: United States
facility: Saint Cloud/Centracare Health
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Edison
country: United States
facility: JFK Neuroscience Institute
state: New Jersey
city: Livingston
country: United States
facility: Cooperman Barnabas Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Hackensack Meridian Jersey Shore University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Brooklyn
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: NYU Langone -Tish Hospital Medical Center
state: New York
city: New York
country: United States
facility: NYP Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Syracuse
country: United States
facility: Suny Upstate Medical University
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center Atrium Health
state: North Carolina
city: Concord
country: United States
facility: Carolinas Rehab Northeast
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neurologic Associates, Inc
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: OSU Wexner Medical Center
state: Ohio
city: West Chester
country: United States
facility: West Chester Hospital
state: Ohio
city: Tulsa
country: United States
facility: St. John Health System
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Hospital Bethlehem Campus
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Richland
state: South Carolina
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Knoxville
country: United States
facility: Fort Sanders Regional Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Methodist University
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Institute of Rehabilitation
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Texas Medical Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Healthcare
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center Main Campus
state: Vermont
city: Charlottesville
country: United States
facility: UVA Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Morgantown
country: United States
facility: Ruby Memorial Hospital
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Foundation
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin University Hospital
state: Wisconsin
Study officials:
affiliation: University of Michigan
name: Devin Brown, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Ronald Chervin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: