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

Itamar-Medical, Israel

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Sleep

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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"

Time frame: 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"

Time frame: 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"

Time frame: 1 night

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.