Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects
Diagnosis of Sleep-related Respiratory Disorders in Patients With Cardiac Disorders Such as Atrial Fibrillation, Heart Failure and Other Comorbidities
Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a synchronized manner.
The PSG data will be scored manually by a trained polysomnographic scorer, according to standard criteria for this clinical routine.
The data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep stages, snoring (optional) and body position (optional), in addition to parameters specific to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and will be compared to the PSG's manual scoring which serves as a "Gold Standard".
연구 개요
상태
정황
상세 설명
Subjects with cardiac disorders, referred to the sleep lab will be offered to participate in the study. Subjects will be asked to sign an informed consent form and will be screened for inclusion exclusion criteria.
Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate pre-study electronic case report forms.
The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP 200/WP200U wrist device, which includes the PAT and pulse oximeter probes will be worn on the wrist.
The investigator will not have access to the WP200/WP200U data while scoring the PSG data. During the study recording, the WP200/WP200U data will be recorded inside the device, without being displayed on the PSG monitor. Furthermore, the WP200/WP200U analysis is done automatically without knowledge of the PSG scoring results.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Berlin, 독일, 10117
- Charité-Universitätsmedizin
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California
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Los Angeles, California, 미국, 95864
- Kaiser Los Angeles
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Los Angeles, California, 미국
- Kaiser Permanente Fontana
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San Jose, California, 미국, 95119
- Kaiser Permanente San Jose
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Florida
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Gainsville, Florida, 미국
- University of Florida
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New York
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Smithtown, New York, 미국
- Stony Brook medical center sleep lab
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Beer Sheva, 이스라엘
- Soroka Medical Center
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Haifa, 이스라엘
- Rambam Medical Health Care Campus
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Tel-Aviv, 이스라엘
- Ichilov Medical Center
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Ontario
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Toronto, Ontario, 캐나다, M3N 1X1
- Centre for Sleep and Chronobiology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age between17-90
- Subject is able to read understand and sign the informed consent form.
- Subject with diagnosed cardiac disorders and/or other comorbidity
- Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab
Exclusion Criteria:
- Permanent pacemaker: atrial pacing or VVI without sinus rhythm
- Finger deformity that precludes adequate sensor appliance.
- Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG
기간: Within 1 year after data collection is complete.
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calculation of the sensitivity, specificity, agreement and correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard" disorders for subjects with cardiac disorders and/or comorbidities, to the manual scoring of the PSG that serves as a "gold standard".
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Within 1 year after data collection is complete.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas Penzel, Prof., Charite University, Berlin, Germany
- 수석 연구원: Richard Berry, Prof., University of Florida
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
수면 장애에 대한 임상 시험
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