Sleep for Stroke Management and Recovery Trial

Stroke Clinical Trial

— Sleep SMART  

Official title:

Sleep for Stroke Management and Recovery Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03812653
• Other study ID #: HUM00147316
• Secondary ID: 1U01NS099043-01A
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: November 2026

Study information

• Verified date: June 2024
• Source: University of Michigan
• Contact: Kayla Novitski, MPH, CCRP
• Email: kcgossel[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 or high risk TIA (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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3062
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. TIA with ABCD2 =4 or ischemic stroke, within the prior 14 days.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Apnea
• CPAP
• Home Sleep Apnea Test
• Ischemic Stroke
• Multicenter Trial
• Randomized Clinical Trial
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke
• Telemedicine
• TIA

Intervention

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

Locations

Country	Name	City	State
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	St. Luke's University Hospital Bethlehem Campus	Bethlehem	Pennsylvania
United States	University of Alabama Hospital	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	NYU Langone Brooklyn	Brooklyn	New York
United States	Buffalo General Medical Center	Buffalo	New York
United States	The University of Vermont Medical Center Main Campus	Burlington	Vermont
United States	Mercy San Juan Medical Center	Carmichael	California
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	Carolinas Medical Center Atrium Health	Charlotte	North Carolina
United States	UVA Medical Center	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois Hospital and Health Sciences System	Chicago	Illinois
United States	Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	UH Cleveland Medical Center	Cleveland	Ohio
United States	Palmetto Health Richland	Columbia	South Carolina
United States	OSU Wexner Medical Center	Columbus	Ohio
United States	Carolinas Rehab Northeast	Concord	North Carolina
United States	Baylor Scott & White Institute of Rehabilitation	Dallas	Texas
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Henry Ford Hospital	Detroit	Michigan
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	JFK Neuroscience Institute	Edison	New Jersey
United States	Inova Fairfax	Falls Church	Virginia
United States	McLaren Flint	Flint	Michigan
United States	UF Health Shands Hospital	Gainesville	Florida
United States	St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	Trinity Health Saint Mary's	Grand Rapids	Michigan
United States	Guilford Neurologic Associates, Inc	Greensboro	North Carolina
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State Milton S. Hershey Center	Hershey	Pennsylvania
United States	Memorial Hermann Texas Medical Center	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Brooks Rehabilitation Hospital	Jacksonville	Florida
United States	UF Jacksonville	Jacksonville	Florida
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Gundersen Lutheran Medical Foundation	La Crosse	Wisconsin
United States	Scripps Memorial	La Jolla	California
United States	UCSD Health La Jolla	La Jolla	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Kaiser Permanente Los Angeles	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Norton HealthCare	Louisville	Kentucky
United States	University of Wisconsin University Hospital	Madison	Wisconsin
United States	North Shore University Hospital	Manhasset	New York
United States	Methodist University	Memphis	Tennessee
United States	Baptist Hospital of Miami	Miami	Florida
United States	Jackson Memorial Hospital	Miami	Florida
United States	University of Miami Hospital	Miami	Florida
United States	Doctors Medical Center of Modesto	Modesto	California
United States	Ruby Memorial Hospital	Morgantown	West Virginia
United States	Intermountain Medical Center	Murray	Utah
United States	Hackensack Meridian Jersey Shore University Medical Center	Neptune	New Jersey
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Ochsner Medical Center - Main Campus	New Orleans	Louisiana
United States	NYP Columbia University Medical Center	New York	New York
United States	NYU Langone -Tish Hospital Medical Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	UCLA Kaiser Fontana	Ontario	California
United States	UC Irvine	Orange	California
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Banner University Medical Center Phoenix	Phoenix	Arizona
United States	Dignity Health - St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	Casa Colina	Pomona	California
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Mayo Clinic Saint Marys Campus	Rochester	Minnesota
United States	Strong Memorial Hospital	Rochester	New York
United States	UC Davis Medical Center	Sacramento	California
United States	Saint Cloud/Centracare Health	Saint Cloud	Minnesota
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	University of Utah Healthcare	Salt Lake City	Utah
United States	UCSD Medical Center - Hillcrest Hospital	San Diego	California
United States	UCSF Helen Diller Medical Center at Parnassus Heights	San Francisco	California
United States	Orange County Global Medical Center	Santa Ana	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Harborview Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	University Health Shreveport	Shreveport	Louisiana
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	Baystate Health	Springfield	Massachusetts
United States	Cox Medical Center	Springfield	Missouri
United States	Memorial Medical Center	Springfield	Illinois
United States	Staten Island University Hospital	Staten Island	New York
United States	Olive View- UCLA Medical Center	Sylmar	California
United States	Suny Upstate Medical University	Syracuse	New York
United States	St. Joseph's Hospital	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Banner- University Medical Center Tucson	Tucson	Arizona
United States	TMC Healthcare	Tucson	Arizona
United States	St. John Health System	Tulsa	Oklahoma
United States	John Muir Medical Center- Walnut Creek Campus	Walnut Creek	California
United States	George Washington University Hospital	Washington	District of Columbia
United States	West Chester Hospital	West Chester	Ohio
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center,	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan	FusionHealth LLC, Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS), University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality	The primary outcome is a time-to-event outcome defined as a participant having at least one of the following events within 6-months from randomization: new ischemic stroke, acute coronary syndrome or all-cause mortality	6 months post randomization
Primary	Modified Rankin Scale Score	Functional outcome as measured by the 9 question modified Rankin Scale (mRS-9Q). The mRS-9Q has 9 questions related to level of function. Outcomes range from 0 (no symptoms) to 6 (death).	3 months post randomization
Secondary	NIH Stroke Score (NIHSS)	Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.	3 months post randomization
Secondary	Short Montreal Cognitive Assessment (MoCA) Score	Cognitive outcome is measured by the Short MoCA. The short MoCA is a 5 minute short version of the Montreal Cognitive Assessment (MoCA). This instrument tests phonemic verbal fluency (1 point), delayed recall (5 points), and orientation (6 points) with a score ranging from 0-12.	3 months post randomization
Secondary	Quality of Life outcome	Quality of life outcome is measured by the shortened Stroke Specific Quality of Life Scale (SS-QOL). The short SS-QOL has 7 domains that include physical function, language, vision, thinking, energy, mood, and role function. There is 1 question from each domain. The 12 item SS-QOL is calculated by averaging the scores of these 12 questions.	3 months post randomization