Sleep for Stroke Management and Recovery Trial (Sleep SMART)

• ClinicalTrials.gov Identifier: NCT03812653
• Recruitment Status: Recruiting
• First Posted: January 23, 2019
• Last Update Posted: December 8, 2022
• Sponsor: University of Michigan
• 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: January 18, 2019
• First Posted Date: January 23, 2019
• Last Update Posted Date: December 8, 2022
• Actual Study Start Date: May 9, 2019
• Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sleep for Stroke Management and Recovery Trial
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

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

Intervention

Device: CPAP

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 18, 2019): 3062
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2023
• Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: United States

Administrative Information

• NCT Number: NCT03812653
• Other Study ID Numbers: 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

• 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: University of Michigan
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: University of Michigan
• Verification Date: December 2022