Evaluation of WP200 With the Unified Probe (WP200U)

Sponsor

Itamar-Medical, Israel (Industry)

Overall Status

Completed

CT.gov ID

NCT01929447

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in addition to the previous episodes also respiratory effort related arousal episodes. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems.

The primary objective of the study is to evaluate the newly developed WP200 with the unified probe (WP200U) compared to the currently used configuration of WP200 that uses an incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorders

Study Design

Study Type:

Observational

Actual Enrollment :

75 participants

Time Perspective:

Prospective

Official Title:

A Prospective, Comparative Study to Evaluate the Watch-PAT200 (WP200) With the Unified Probe (WP200U) Compared to the Currently Used Configuration of WP200 With the Nonin Oximetry Module

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Sep 1, 2014

Outcome Measures

Primary Outcome Measures

Sleep respiratory parameters [3 years]
pRDI, pAHI, ODI

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 5-90
Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are either referred or volunteering to undergo an overnight sleep study in the clinical sleep laboratory or at home

Exclusion Criteria:

Permanent pacemaker.
Severe lung disease.
Severe peripheral neuropathy.
Finger deformity that precludes adequate sensor appliance.
Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).