Evaluation of WP200 With the Unified Probe (WP200U)

Sleep Disorders Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929447
• Other study ID #: Carmel-002
• Status: Completed
• Phase: N/A
• First received: August 20, 2013
• Last updated: September 18, 2014
• Start date: October 2013

Study information

• Verified date: September 2014
• Source: Itamar-Medical, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 90 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Itamar-Medical, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep respiratory parameters	pRDI, pAHI, ODI	3 years	No