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

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Itamar-Medical, Israel
Updated on 18 April 2022
apnea
polysomnography
Accepts healthy volunteers

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".

Details
Condition Sleep Disorders
Clinical Study IdentifierNCT01570738
SponsorItamar-Medical, Israel
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age between 5-90
Subjects that are able to read understand and sign the informed consent form to undergo an overnight sleep study in the clinical sleep laboratory

Exclusion Criteria

Permanent pacemaker
Severe lung disease
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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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