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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PSG and WatchPAT200 in subjects age12-17

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

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes