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NCT01683721 Clinical Trial

Post-Market Observational Study of the WINX Sleep Therapy for the Treatment of Obstructive Sleep Apnea (OSA)

Obstructive Sleep Apnea Clinical Trial

— UNMASK  

Official title:
The UNMASK Study: A Post-Market Longitudinal Observational Study of the WinxTM Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01683721
Other study ID # 12023
Secondary ID
Status Recruiting
Phase N/A
First received September 7, 2012
Last updated September 3, 2013
Start date September 2012
Est. completion date February 2014

Study information
Verified date September 2013
Source ApniCure, Inc.
Contact Lawrence Siegel, MD
Phone 650-361-9399
Email lsiegel@apnicure.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Exclusion Criteria

- Has a severe respiratory disorder, such as severe lung disease, pneumothorax, etc.

- Has loose teeth or advanced periodontal disease.

- Is under the age of 18.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Sleep Medicine Associates of Texas (SMAT) Dallas Texas
United States St. Petersburg Sleep Disorders Center St. Petersburg Florida

Sponsors (1)
Lead Sponsor Collaborator
ApniCure, Inc.

Country where clinical trial is conducted

United States, 

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