CPAP, Home Sleep Apnea Test, Ischemic Stroke, Multicenter Trial, Randomized Clinical Trial, Sleep Apnea, Sleep Apnea, Obstructive, Stroke, Telemedicine
Conditions
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.
Interventions
DEVICECPAP
Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
Sponsors
University of Michigan
National Institute of Neurological Disorders and Stroke (NINDS)
FusionHealth LLC
Medical University of South Carolina
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.
Intervention model description
Intervention group receives automatically adjusting continuous positive airway pressure (CPAP) plus usual care.The control group receives usual care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDevin Brown, MD, MS
University of Michigan
PRINCIPAL_INVESTIGATORRonald Chervin, MD, MS
University of Michigan
Outcome results
None listed