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Completed

NCT Number: NCT01929447

Evaluation of WP200 With the Unified Probe (WP200U)

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.

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Key information

Conditions

Sleep Disorders Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

5 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Carmel Medical Center

Haifa, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Sleep respiratory parameters

    Time frame: 3 years

    pRDI, pAHI, ODI

Sponsors and collaborators

Lead sponsor

Itamar-Medical, Israel

Industry

Registry information

Official study title

A Prospective, Comparative Study to Evaluate the Watch-PAT200 (WP200) With the Unified Probe (WP200U) Compared to the Currently Used Configuration of WP200 With the Nonin Oximetry Module

Important dates

Study start
2013
Primary completion
2014
First posted
Aug 28, 2013
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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