Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects
Completed
Conditions studied: Sleep Disorders
In brief
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".
Key facts
- Study ID
- NCT02369705
- Run by
- Itamar-Medical, Israel
- People needed
- 200
- Starts
- 2015-06-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-07-15
Who can join
Age: 17 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- 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 — Beersheba, Israel
- Rambam Medical Health Care Campus — Haifa, Israel
- Ichilov Medical Center — Tel Aviv, Israel
Full record on ClinicalTrials.gov
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