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".
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 10117
- Charité-Universitätsmedizin
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Ontario
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Toronto, Ontario, Canadá, M3N 1X1
- Centre for Sleep and Chronobiology
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California
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Los Angeles, California, Estados Unidos, 95864
- Kaiser Los Angeles
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Los Angeles, California, Estados Unidos
- Kaiser Permanente Fontana
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San Jose, California, Estados Unidos, 95119
- Kaiser Permanente San Jose
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Florida
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Gainsville, Florida, Estados Unidos
- University of Florida
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New York
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Smithtown, New York, Estados Unidos
- Stony Brook medical center sleep lab
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Beer Sheva, Israel
- Soroka Medical Center
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Haifa, Israel
- Rambam Medical Health Care Campus
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Tel-Aviv, Israel
- Ichilov Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Penzel, Prof., Charite University, Berlin, Germany
- Investigador principal: Richard Berry, Prof., University of Florida
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WP200/U-Cardio-001
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