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 : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Sleep Apnea Sleep Apnea, Obstructive TIA Stroke CPAP Telemedicine Home Sleep Apnea Test Randomized Clinical Trial Multicenter Trial||Device: CPAP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3062 participants|
|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.|
|Official Title:||Sleep for Stroke Management and Recovery Trial|
|Actual Study Start Date :||May 9, 2019|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
Experimental: Intervention Arm: CPAP with Usual Care.
6 months of CPAP plus usual medical therapy.
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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812653
|Contact: Kayla Novitski, MPHfirstname.lastname@example.org|
|Contact: Joelle Sickler, MSN, CCRC, CCRAemail@example.com|
|Principal Investigator:||Devin Brown, MD, MS||University of Michigan|
|Principal Investigator:||Ronald Chervin, MD, MS||University of Michigan|