Evaluation of WP200 With the Unified Probe (WP200U)

Completed

• Conditions: Sleep Disorders

• Registration Number: NCT01929447
• Lead Sponsor: Itamar-Medical, Israel

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-28
• Study Start: 2013-10
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep respiratory parameters	3 years	pRDI, pAHI, ODI

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel