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Sleep for Stroke Management and Recovery Trial (Sleep SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812653
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : December 8, 2022
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
FusionHealth LLC
Medical University of South Carolina
University of Cincinnati
Information provided by (Responsible Party):
Devin L. Brown, MD, University of Michigan

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 23, 2019
Last Update Posted Date December 8, 2022
Actual Study Start Date  ICMJE May 9, 2019
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality [ Time Frame: 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
  • Modified Rankin Scale Score [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • NIH Stroke Score (NIHSS) [ Time Frame: 3 months post randomization ]
    Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.
  • Short Montreal Cognitive Assessment (MoCA) Score [ Time Frame: 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.
  • Quality of Life outcome [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep for Stroke Management and Recovery Trial
Official Title  ICMJE Sleep for Stroke Management and Recovery Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
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
Condition  ICMJE
  • Ischemic Stroke
  • Sleep Apnea
  • Sleep Apnea, Obstructive
  • TIA
  • Stroke
  • CPAP
  • Telemedicine
  • Home Sleep Apnea Test
  • Randomized Clinical Trial
  • Multicenter Trial
Intervention  ICMJE Device: CPAP
Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
Study Arms  ICMJE
  • Experimental: Intervention Arm: CPAP with Usual Care.
    6 months of CPAP plus usual medical therapy.
    Intervention: Device: CPAP
  • No Intervention: Control Arm: Usual Care.
    6 months of usual medical therapy alone.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2019)
3062
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kayla Novitski, MPH, CCRP 734-615-2006 kcgossel@med.umich.edu
Contact: Joelle Sickler, MSN, CCRC, CCRA sicklejb@ucmail.uc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03812653
Other Study ID Numbers  ICMJE HUM00147316
1U01NS099043-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We will comply with the NIH Data Sharing Policy, Policy on the Dissemination of NIH-Funded Clinical Trial Information, the Clinical Trials Registration and Results Information Submission rule, and StrokeNet SOP on Network Data Sharing Policy. NDMC statisticians will generate data files from each data table and in compliance with HIPAA regulations each table will be de-identified. A minimum number of derived variables necessary to reproduce the primary analysis will be created. Within a year from acceptance of the primary manuscript or no later than two years from database lock, the public-use data sets will be submitted to the NINDS data repository along with final version of the study protocol, data dictionary and a user guide. Data along with signals from sleep apnea recordings will be submitted to the NHLBI National Sleep Research Resource.
Current Responsible Party Devin L. Brown, MD, University of Michigan
Original Responsible Party Devin Brown, University of Michigan, Professor of Neurology
Current Study Sponsor  ICMJE University of Michigan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • FusionHealth LLC
  • Medical University of South Carolina
  • University of Cincinnati
Investigators  ICMJE
Principal Investigator: Devin Brown, MD, MS University of Michigan
Principal Investigator: Ronald Chervin, MD, MS University of Michigan
PRS Account University of Michigan
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP