Evaluation of WP200 With the Unified Probe (WP200U)

NCT01929447 | Completed

• 1 other identifier: Carmel-002
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders

Keywords

sleep disorders; sleep apnea; ambulatory device; WatchPAT

Outcome Measures

Primary Outcomes (1)

• Sleep respiratory parameters

  pRDI, pAHI, ODI

  3 years

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects, adults and children, with suspected sleep disorders who are referred to a sleep study and are willing to participate in this clinical study. Additional non selective volunteers who are willing to participate in this clinical study and consent to undergo an overnight sleep study at their home.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Itamar-Medical, Israel: lead

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 28, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

IL (1)