Trials / Withdrawn
WithdrawnNCT02378831
Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters
Testing for Sleep Apnea in Adolescence Subjects With the WP200/WP200U Compared to an In-lab Overnight PSG Testing
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Itamar-Medical, Israel · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG data, performed by a trained and authorized scorer, according to the AASM (American Academy of Sleep Medicine) guidelines, serves as a "gold standard" for all determinations of efficacy.
Conditions
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2016-07-01
- First posted
- 2015-03-04
- Last updated
- 2015-08-27
Source: ClinicalTrials.gov record NCT02378831. Inclusion in this directory is not an endorsement.