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Sleep for Stroke Management And Recovery Trial (Sleep SMART)

Award Number: U01NS099043
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2018
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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Sleep for Stroke Management And Recovery Trial (Sleep SMART) - Treatment of obstructive sleep apnea (OSA) for stroke prevention and recovery represents a rare chance to achieve transformative impact on post-stroke care and outcomes. OSA is highly prevalent after stroke (~75%) and is a known risk factor for poor functional outcome, mortality, and recurrent stroke. Furthermore, OSA is readily treated by a safe, simple, and relatively low-cost therapy, continuous positive airway pressure (CPAP). Observational studies have already demonstrated better stroke outcomes among patients who use CPAP, and multiple pilot trials have hinted at the benefits of CPAP after stroke. These studies have laid the foundation for a definitive trial on the role of CPAP in post-stroke management. The pressing need for this critical next step is highlighted in the latest American Stroke Association secondary stroke prevention guidelines. Therefore, the investigators now propose a phase III, open-label, blinded-endpoint assessment, multicenter, randomized, controlled trial to determine (1) whether treatment of OSA with CPAP after acute ischemic stroke or high-risk transient ischemic attack (TIA) helps to prevent recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) whether treatment of OSA shortly after acute ischemic stroke improves stroke outcomes at 3 months. This study capitalizes on an efficient and cost-saving design involving a 6-month prevention trial with an embedded 3-month recovery trial. Many years of pilot work have identified the challenges related to the diagnosis and treatment of OSA after stroke. These valuable insights - combined with innovative digital and biomedical technology - have contributed to this highly pragmatic trial in which feasibility is paramount. In particular, as polysomnography and CPAP titration are seldom tolerated just after acute stroke, OSA will be identified through use of a portable cardiopulmonary sleep apnea test, and treated with an automatically adjusting CPAP device. Through state-of-the-art methods, subjects will receive centralized, real-time, nightly monitoring of CPAP use and proactive care management to maximize CPAP adherence. This approach simplifies and streamlines the diagnosis and treatment of OSA, which will facilitate implementation in hospitals with low resources. Consequently, this trial provides StrokeNet with an opportunity to use its network more fully, and will permit positive trial results to be readily translated into community settings across the U.S. This study represents a rare opportunity to change post-stroke care in a fundamental manner with a safe, cost-effective intervention that could improve both recovery and prevention in a substantial proportion of patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1 )
2026	2026	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	5/11/2026	NON-COMPETING CONTINUATION	$1
														Subtotal = $1

Issue Date FY: 2025 ( Subtotal = $6,179,571 )
2025	2025	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	5/30/2025	NON-COMPETING CONTINUATION	$6,179,571
														Subtotal = $6,179,571

Issue Date FY: 2024 ( Subtotal = $7,753,805 )
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	8/8/2024	NON-COMPETING CONTINUATION	$7,753,805
2024	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	6/17/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $7,753,805

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	9/26/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/2/2022	NON-COMPETING CONTINUATION	$0
2022	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	8/31/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	6/23/2021	NON-COMPETING CONTINUATION	$0
2021	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	3/2/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $10,318,523 )
2020	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/4/2020	NON-COMPETING CONTINUATION	$10,318,523
														Subtotal = $10,318,523

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	1	8/20/2019	NEW	$0
2019	2018	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	6/17/2019	NEW	$0
2019	2018	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	11/14/2018	NEW	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $7,487,394 )
2018	2018	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/13/2018	NEW	$7,487,394
														Subtotal = $7,487,394

Grand Total All Awards = $31,739,294

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Sleep for Stroke Management And Recovery Trial (Sleep SMART)

Award Number: U01NS099043

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2018

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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