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Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Sleep Disorders Clinical Trial

Official title:
Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory

Clinical Trial Summary

Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The prevalence of snoring in children is high - 5% in the age group of 6 and less and about 1.5% above. The in-lab sleep study using full Polysomnography (PSG) and the manual scoring criteria set by the American Academy of Sleep Medicine was considered the gold standard for OSAS diagnosis. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the commonly used procedure of "split-night" for OSAS patients, as well as to the development of a variety of ambulatory sleep study systems. The primary study objective is to compare the efficacy of the WatchPAT (WP), as an ambulatory device for aiding in the diagnosis of sleep disorders for subjects from age 5 to 90, to the manual scoring of the PSG that serves as a "gold standard".

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01570738
Study type Observational
Source Itamar-Medical, Israel
Contact
Status Completed
Phase
Start date July 2012
Completion date June 2022
View Details
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