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

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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.

Tracking Information
First Submitted Date September 7, 2012
First Posted Date September 12, 2012
Last Update Posted Date September 4, 2013
Study Start Date September 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01683721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Market Observational Study of the WINX Sleep Therapy for the Treatment of Obstructive Sleep Apnea (OSA)
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)
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects with obstructive sleep apnea (OSA)
Condition Obstructive Sleep Apnea
Intervention Not Provided
Study Groups/Cohorts Winx
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September¬†10,¬†2012)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01683721
Other Study ID Numbers 12023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ApniCure, Inc.
Study Sponsor ApniCure, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account ApniCure, Inc.
Verification Date September 2013