- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02454023
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART)
SLEep APnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke (SLEAP SMART): A Randomized Controlled Trial
연구 개요
상태
상세 설명
Obstructive sleep apnea (OSA) is common after stroke and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite its high prevalence, OSA often remains underdiagnosed after stroke. While in-laboratory polysomnography studies are the gold standard for diagnosing OSA, their use is limited by the lack of availability, patient unwillingness to sleep overnight at a laboratory and high costs. Home-based PSMs can accurately diagnose OSA and are much more accessible, convenient and low-priced compared to in-laboratory sleep studies.
The primary purpose of this study is to determine whether broad screening for OSA using PSMs, as compared to usual care, increases the proportion of patients diagnosed with treatable OSA after stroke or TIA. Secondary aims include whether screening with PSMs increases the proportion of patients treated for OSA with continuous positive airway pressure (CPAP) and whether functional outcomes and sleep-related outcomes are improved. Finally, the study will also determine whether this approach is cost-effective.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다
- Sunnybrook Health Sciences Centre
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Imaging-confirmed stroke or stroke-neurologist diagnosed TIA in the past 6-months, and
- Outpatients being managed at the Sunnybrook Stroke Prevention clinic or inpatients on the Sunnybrook Stroke Unit.
Exclusion Criteria:
- Prior diagnosis of OSA
- Current use of CPAP
- Life expectancy less than 12 months
- The presence of conditions known to compromise the accuracy of portable sleep monitoring, such as moderate to severe pulmonary disease or congestive heart failure
- Oxygen therapy (eg. nasal prongs), a nasogastric tube, or other medical devices that would interfere with the placement of the sensors of the sleep monitoring device and/or CPAP
- Physical impairment, aphasia, or language barrier restricting ability to complete study assessments, overnight sleep monitoring, and/or comply with CPAP therapy, and no caregiver available to assist the patient with the study requirements
- Facial or bulbar weakness or trauma restricting the ability to create a seal with a CPAP mask
- Pregnancy
- Occupation that would make randomization to the standard of care arm unethical
- Not covered by Ontario health insurance plan (OHIP)
- Unable to attend follow-up assessments
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Standard of care
Patients receive usual standard of care for investigating obstructive sleep apnea after stroke/transient ischemic attack, which is in-laboratory polysomnography.
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폐쇄성 수면 무호흡증 검출을 위한 레벨 1 검사실 내 수면다원검사.
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실험적: Portable sleep monitor (ApneaLink Air)
Patients will undergo screening for obstructive sleep apnea using the ApneaLink Air portable sleep monitor.
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Use of a portable sleep monitor that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Proportion of patients diagnosed with treatable OSA
기간: 6 & 12 months
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Proportion of patients diagnosed with treatable OSA by 6 & 12 months
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6 & 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
각 관리 전략 및 치료를 제공하는 데 드는 비용
기간: 6 개월
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각 관리 전략 및 치료를 6개월까지 제공하는 데 드는 비용
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6 개월
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Proportion of patients prescribed CPAP for treatable OSA
기간: 6 & 12 months
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Proportion of patients prescribed CPAP for treatable OSA by 6 & 12 months
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6 & 12 months
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Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire)
기간: 6 months
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Sleep-related quality of life (Functional Outcomes of Sleep Quality questionnaire) at 6 months
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6 months
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Daytime sleepiness (Epworth Sleepiness Scale)
기간: 6 & 12 months
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Daytime sleepiness (Epworth Sleepiness Scale) at 6 & 12 months
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6 & 12 months
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Neurological outcomes (as assessed by the Stroke Impact Scale)
기간: 6 months
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Neurological outcomes (as assessed by the Stroke Impact Scale) at 6 months
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6 months
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Neurological outcomes (as assessed by the modified Rankin scale)
기간: 6 months
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Neurological outcomes (as assessed by the modified Rankin scale) at 6 months
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6 months
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Neurological outcomes (as assessed by the National Institutes of Health stroke scale)
기간: 6 months
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Neurological outcomes (as assessed by the National Institutes of Health stroke scale) at 6 months
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6 months
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24-hr ambulatory blood pressure
기간: 6 months
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24-hr ambulatory blood pressure at 6 months
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6 months
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New vascular events (stroke, TIA, myocardial infarction, coronary artery stenting)
기간: 12 months
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Assessed via telephone call at 12 months
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mark I Boulos, MD, MSc, Sunnybrook Research Institute
간행물 및 유용한 링크
일반 간행물
- Boulos MI, Colelli DR, Vaccarino SR, Kamra M, Murray BJ, Swartz RH. Using a modified version of the "STOP-BANG" questionnaire and nocturnal oxygen desaturation to predict obstructive sleep apnea after stroke or TIA. Sleep Med. 2019 Apr;56:177-183. doi: 10.1016/j.sleep.2018.12.021. Epub 2019 Jan 7.
- Colelli DR, Kamra M, Rajendram P, Murray BJ, Boulos MI. Predictors of CPAP adherence following stroke and transient ischemic attack. Sleep Med. 2020 Feb;66:243-249. doi: 10.1016/j.sleep.2018.10.009. Epub 2018 Oct 24.
- Boulos MI, Kamra M, Colelli DR, Kirolos N, Gladstone DJ, Boyle K, Sundaram A, Hopyan JJ, Swartz RH, Mamdani M, Loong D, Isaranuwatchai W, Murray BJ, Thorpe KE. SLEAP SMART (Sleep Apnea Screening Using Mobile Ambulatory Recorders After TIA/Stroke): A Randomized Controlled Trial. Stroke. 2022 Mar;53(3):710-718. doi: 10.1161/STROKEAHA.120.033753. Epub 2021 Oct 11.
- MacDonald AA, Rajendram P, Kamra M, Murray BJ, MacDonald PA, Boulos MI. Predictors of in-laboratory polysomnography attendance in a cohort of patients with stroke or TIA. Sleep Med. 2020 Feb;66:159-164. doi: 10.1016/j.sleep.2019.10.002. Epub 2019 Oct 14.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 116-2015
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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