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Evaluation of WP200 With the Unified Probe (WP200U)

NCT01929447 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2014-09-19

No results posted yet for this study

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.

Conditions

  • Sleep Disorders

Sponsors & Collaborators

  • Itamar-Medical, Israel

    lead INDUSTRY

Eligibility

Min Age
5 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929447 on ClinicalTrials.gov