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

Itamar Medical

Status: Withdrawn

Conditions: Sleep

Study type: Observational

Funder types: Industry

Identifiers

NCT02378831

WP200/U-adolescence- 001

Details and patient eligibility

About

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.

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

0 participants in 1 patient group

PSG and WatchPAT200 in subjects age12-17

Description:

Adolescents refered to a sleep lab for sleep lab for full night PSG