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

Completed

• Conditions: Sleep Disorders

• Registration Number: NCT01570738
• Lead Sponsor: Itamar-Medical, Israel

Brief 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".

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Study Start: 2012-07
• Status Verified: 2022-03
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

1. Age between 5-90
2. 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

1. Permanent pacemaker.
2. Severe lung disease.
3. Peripheral neuropathy.
4. Finger deformity that precludes adequate sensor appliance.
5. 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare sleep data collected from the Watch-PAT device to PSG data	3 years

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel