Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters

Withdrawn

• Conditions: Sleep

• Registration Number: NCT02378831
• Lead Sponsor: Itamar-Medical, Israel

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-02
• Study First Submitted: 2015-02-17
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-04
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-08-27
• Study Start: 2016-03
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age between 12-17
• Subjects with a legal guardian that is able to read understand and sign the informed consent form
• 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.
• 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
sensitivity, specificity, obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"	1 night
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"	1 night
Agreement obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard"	1 night