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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by ApniCure, Inc.
Sponsor:
Information provided by (Responsible Party):
ApniCure, Inc.
ClinicalTrials.gov Identifier:
NCT01683721
First received: September 7, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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
Obstructive Sleep Apnea

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by ApniCure, Inc.:

Estimated Enrollment: 1000
Study Start Date: September 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683721

Contacts
Contact: Lawrence Siegel, MD 650-361-9399 lsiegel@apnicure.com

Locations
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

No publications provided

Responsible Party: ApniCure, Inc.
ClinicalTrials.gov Identifier: NCT01683721     History of Changes
Other Study ID Numbers: 12023
Study First Received: September 7, 2012
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 27, 2014