Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01683721
Recruitment Status : Unknown
Verified September 2013 by ApniCure, Inc..
Recruitment status was:  Recruiting
First Posted : September 12, 2012
Last Update Posted : September 4, 2013
Sponsor:
Information provided by (Responsible Party):
ApniCure, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease
Obstructive Sleep Apnea

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : September 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Winx


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with obstructive sleep apnea (OSA)
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683721


Contacts
Layout table for location contacts
Contact: Lawrence Siegel, MD 650-361-9399 lsiegel@apnicure.com

Locations
Layout table for location information
United States, Florida
St. Petersburg Sleep Disorders Center Recruiting
St. Petersburg, Florida, United States, 33707
Contact    727-360-0853      
Principal Investigator: Neil T Feldman, MD         
United States, Texas
Sleep Medicine Associates of Texas (SMAT) Recruiting
Dallas, Texas, United States, 75231
Contact: Philip Becker, MD    214-389-1740      
Principal Investigator: Philip Becker, MD         
Sponsors and Collaborators
ApniCure, Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ApniCure, Inc.
ClinicalTrials.gov Identifier: NCT01683721    
Other Study ID Numbers: 12023
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases