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Sleep SMART: Sleep for Stroke Management and Recovery Trial

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT03812653
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH), FusionHealth LLC (Other), Medical University of South Carolina (Other), University of Cincinnati (Other)
3,062
Enrollment
120
Locations
2
Arms
53.8
Anticipated Duration (Months)
25.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: CPAP
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3062 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
Masking:
Single (Outcomes Assessor)
Masking Description:
Eligible participants will be allocated in a 1:1 fashion to CPAP or no CPAP using a randomization method to protect subject treatment allocation and prevent potential selection biases.
Primary Purpose:
Prevention
Official Title:
Sleep for Stroke Management and Recovery Trial
Actual Study Start Date :
May 9, 2019
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Arm: CPAP with Usual Care.

6 months of CPAP plus usual medical therapy.

Device: CPAP
Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
No Intervention: Control Arm: Usual Care.

6 months of usual medical therapy alone.

Outcome Measures

Primary Outcome Measures

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

    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

  2. Modified Rankin Scale Score [3 months post randomization]

    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).

Secondary Outcome Measures

  1. NIH Stroke Score (NIHSS) [3 months post randomization]

    Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.

  2. Short Montreal Cognitive Assessment (MoCA) Score [3 months post randomization]

    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. Quality of Life outcome [3 months post randomization]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama Hospital Birmingham Alabama United States 35294
2 Chandler Regional Medical Center Chandler Arizona United States 85224
3 Banner University Medical Center Phoenix Phoenix Arizona United States 85006
4 Dignity Health - St. Joseph's Hospital and Medical Center Phoenix Arizona United States 85013
5 Mayo Clinic Arizona Phoenix Arizona United States 85054
6 TMC Healthcare Tucson Arizona United States 85712
7 Banner- University Medical Center Tucson Tucson Arizona United States 85719
8 Mercy San Juan Medical Center Carmichael California United States 95608
9 UCSD Health La Jolla La Jolla California United States 92103
10 Cedars-Sinai Medical Center Los Angeles California United States 90048
11 Ronald Reagan UCLA Medical Center Los Angeles California United States 90095
12 Kaiser Permanente Los Angeles Los Angeles California United States 94612
13 Doctors Medical Center of Modesto Modesto California United States 95355
14 UCLA Kaiser Fontana Ontario California United States 91761
15 UC Irvine Orange California United States 92868
16 UC Davis Medical Center Sacramento California United States 95817
17 UCSD Medical Center - Hillcrest Hospital San Diego California United States 92103
18 UCSF Helen Diller Medical Center at Parnassus Heights San Francisco California United States 94143
19 Orange County Global Medical Center Santa Ana California United States 92705
20 Olive View- UCLA Medical Center Sylmar California United States 91342
21 John Muir Medical Center- Walnut Creek Campus Walnut Creek California United States 94598
22 St. Mary's Hospital and Medical Center Grand Junction Colorado United States 81501
23 Bridgeport Hospital Bridgeport Connecticut United States 06610
24 Hartford Hospital Hartford Connecticut United States 06102
25 Yale-New Haven Hospital New Haven Connecticut United States 06510
26 George Washington University Hospital Washington District of Columbia United States 20037
27 UF Health Shands Hospital Gainesville Florida United States 32611
28 Brooks Rehabilitation Hospital Jacksonville Florida United States 32216
29 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
30 Jackson Memorial Hospital Miami Florida United States 33136
31 University of Miami Hospital Miami Florida United States 33136
32 Baptist Hospital of Miami Miami Florida United States 33176
33 Sarasota Memorial Hospital Sarasota Florida United States 34239
34 Tampa General Hospital Tampa Florida United States 33606
35 Rush University Medical Center Chicago Illinois United States 60612
36 University of Illinois Hospital and Health Sciences System Chicago Illinois United States 60612
37 University of Chicago Chicago Illinois United States 60637
38 Loyola University Medical Center Maywood Illinois United States 60513
39 OSF Saint Francis Medical Center Peoria Illinois United States 61603
40 Memorial Medical Center Springfield Illinois United States 62702
41 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
42 St Elizabeth Healthcare NKY Edgewood Kentucky United States 41017
43 University of Kentucky Albert B. Chandler Hospital Lexington Kentucky United States 40526
44 University of Louisville Hospital Louisville Kentucky United States 40202
45 Norton HealthCare Louisville Kentucky United States 40218
46 Ochsner Medical Center - Main Campus New Orleans Louisiana United States 70121
47 University Health Shreveport Shreveport Louisiana United States 71103
48 University of Maryland Baltimore Maryland United States 21201
49 Tufts Medical Center Boston Massachusetts United States 02111
50 Massachusetts General Hospital Boston Massachusetts United States 02114
51 Brigham and Women's Hospital Boston Massachusetts United States 02115
52 Boston Medical Center Boston Massachusetts United States 02118
53 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
54 Baystate Health Springfield Massachusetts United States 01199
55 Detroit Receiving Hospital Detroit Michigan United States 48201
56 Henry Ford Hospital Detroit Michigan United States 48202
57 McLaren Flint Flint Michigan United States 48532
58 Mary Free Bed Rehabilitation Hospital Grand Rapids Michigan United States 49503
59 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
60 Bronson Methodist Hospital Kalamazoo Michigan United States 49008
61 University of Minnesota Medical Center Minneapolis Minnesota United States 55455
62 Mayo Clinic Saint Marys Campus Rochester Minnesota United States 55905
63 Saint Cloud/Centracare Health Saint Cloud Minnesota United States 56303
64 University of Mississippi Medical Center Jackson Mississippi United States 39216
65 Boone Hospital Center Columbia Missouri United States 65201
66 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
67 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
68 SSM Health Saint Louis University Hospital Saint Louis Missouri United States 63110
69 Cox Medical Center Springfield Missouri United States 65807
70 University of Nebraska Medical Center Omaha Nebraska United States 68198
71 University of New Mexico Hospital Albuquerque New Mexico United States 87106
72 Montefiore Medical Center Bronx New York United States 10467
73 Maimonides Medical Center Brooklyn New York United States 11219
74 NYU Langone Brooklyn Brooklyn New York United States 11220
75 Buffalo General Medical Center Buffalo New York United States 14203
76 North Shore University Hospital Manhasset New York United States 11030
77 NYU Langone -Tish Hospital Medical Center New York New York United States 10016
78 NYP Columbia University Medical Center New York New York United States 10032
79 Strong Memorial Hospital Rochester New York United States 14642
80 Staten Island University Hospital Staten Island New York United States 10305
81 Suny Upstate Medical University Syracuse New York United States 13210
82 Carolinas Medical Center Atrium Health Charlotte North Carolina United States 28203
83 Carolinas Rehab Northeast Concord North Carolina United States 28025
84 Guilford Neurologic Associates, Inc Greensboro North Carolina United States 27401
85 Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157
86 Sanford Medical Center Fargo North Dakota United States 58104
87 Christ Hospital Cincinnati Ohio United States 45219
88 University of Cincinnati Medical Center Cincinnati Ohio United States 45219
89 UH Cleveland Medical Center Cleveland Ohio United States 11100
90 MetroHealth Medical Center Cleveland Ohio United States 44109
91 Cleveland Clinic Cleveland Ohio United States 44195
92 OSU Wexner Medical Center Columbus Ohio United States 43210
93 Promedica Toledo Hospital Toledo Ohio United States 43606
94 West Chester Hospital West Chester Ohio United States 45069
95 St. John Health System Tulsa Oklahoma United States 74104
96 Providence St. Vincent Medical Center Portland Oregon United States 97225
97 Oregon Health & Science University Hospital Portland Oregon United States 97239
98 St. Luke's University Hospital Bethlehem Campus Bethlehem Pennsylvania United States 18015
99 Geisinger Clinic Danville Pennsylvania United States 17822
100 Penn State Milton S. Hershey Center Hershey Pennsylvania United States 17033
101 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
102 Temple University Hospital Philadelphia Pennsylvania United States 19122
103 UPMC Presbyterian Hospital Pittsburgh Pennsylvania United States 15213
104 Palmetto Health Richland Columbia South Carolina United States 29203
105 Greenville Memorial Hospital Greenville South Carolina United States 29605
106 Methodist University Memphis Tennessee United States 38105
107 University of Texas Southwestern Medical Center Dallas Texas United States 75235
108 Baylor Scott & White Institute of Rehabilitation Dallas Texas United States 75246
109 Valley Baptist Medical Center Harlingen Texas United States 78550
110 Memorial Hermann Texas Medical Center Houston Texas United States 77030
111 Intermountain Medical Center Murray Utah United States 84107
112 University of Utah Healthcare Salt Lake City Utah United States 84132
113 The University of Vermont Medical Center Main Campus Burlington Vermont United States 05401
114 UVA Medical Center Charlottesville Virginia United States 22908
115 Inova Fairfax Falls Church Virginia United States 22042
116 Virginia Mason Medical Center Seattle Washington United States 98101
117 Harborview Medical Center Seattle Washington United States 98195
118 Ruby Memorial Hospital Morgantown West Virginia United States 26506
119 Gundersen Lutheran Medical Foundation La Crosse Wisconsin United States 54601
120 University of Wisconsin University Hospital Madison Wisconsin United States 53715

Sponsors and Collaborators

  • University of Michigan
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • FusionHealth LLC
  • Medical University of South Carolina
  • University of Cincinnati

Investigators

  • Principal Investigator: Devin Brown, MD, MS, University of Michigan
  • Principal Investigator: Ronald Chervin, MD, MS, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Devin L. Brown, MD, Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier:
NCT03812653
Other Study ID Numbers:
  • HUM00147316
  • 1U01NS099043-01A1
First Posted:
Jan 23, 2019
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Stroke
Ischemic Stroke

Study Results

No Results Posted as of Mar 28, 2022