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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.

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

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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

Group/Cohort
Winx




Information from the National Library of Medicine

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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.

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

Locations
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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.

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Responsible Party: ApniCure, Inc.
ClinicalTrials.gov Identifier: NCT01683721     History of Changes
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:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases