Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects
- Conditions
- Sleep Disorders
- Registration Number
- NCT02369705
- Lead Sponsor
- Itamar-Medical, Israel
- Brief Summary
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".
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG Within 1 year after data collection is complete. 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".
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Kaiser Los Angeles
🇺🇸Los Angeles, California, United States
Kaiser Permanente Fontana
🇺🇸Los Angeles, California, United States
Kaiser Permanente San Jose
🇺🇸San Jose, California, United States
University of Florida
🇺🇸Gainsville, Florida, United States
Stony Brook medical center sleep lab
🇺🇸Smithtown, New York, United States
Centre for sleep and Chronobiology
🇨🇦Toronto, Ontario, Canada
Charité-Universitätsmedizin
🇩🇪Berlin, Germany
Soroka Medical Center
🇮🇱Beer Sheva, Israel
Rambam Medical Health Care Campus
🇮🇱Haifa, Israel
Ichilov Medical Center
🇮🇱Tel-Aviv, Israel
Kaiser Los Angeles🇺🇸Los Angeles, California, United States