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NCT02369705 · ClinicalTrials.gov registry record
Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects
A clinical trial, sponsored by Itamar-Medical, Israel.
- Completed
- Registry status
- 200
- Enrollment target
NCT02369705: Completed study, sponsored by Itamar-Medical, Israel.
NCT02369705 is a clinical trial that has completed, run by Itamar-Medical, Israel. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02369705 has completed, sponsored by Itamar-Medical, Israel.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study 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".
Primary Outcome
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".
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-06 |
What the finished NCT02369705 record still lists
NCT02369705 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02369705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02369705 about?
NCT02369705 is a clinical study titled "Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects". 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 ...
What is the current status of trial NCT02369705?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2015-06. Estimated completion is 2016-06.
Who is sponsoring clinical trial NCT02369705?
This trial is sponsored by Itamar-Medical, Israel, which has 5 total clinical trials registered on ClinicalTrials.gov.
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