Post-Market Observational Study of the WINX Sleep Therapy for the Treatment of Obstructive Sleep Apnea (OSA) (UNMASK)
This study is currently recruiting participants.
Verified September 2012 by ApniCure, Inc.
Sponsor:
ApniCure, Inc.
Information provided by (Responsible Party):
ApniCure, Inc.
ClinicalTrials.gov Identifier:
NCT01683721
First received: September 7, 2012
Last updated: October 18, 2012
Last verified: September 2012
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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) |
| Groups/Cohorts |
|---|
| Winx |
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
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, Arizona | |
| REM Medical | Recruiting |
| Phoenix, Arizona, United States, 85037 | |
| Contact: Rochelle Goldberg, MD 623-271-9323 | |
| Principal Investigator: Rochelle Goldberg, MD | |
| United States, California | |
| Peninsula Sleep Lab | Recruiting |
| Burlingame, California, United States, 94010 | |
| Contact: Mehran Farid-Moayer, MD 650-636-9396 | |
| Principal Investigator: Mehran Farid-Moayer, MD | |
| United States, Georgia | |
| Sleep Disorders Center of Georgia (SDCG) | Not yet recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Alan Lankford, PhD 404-257-0080 | |
| Principal Investigator: Alan Lankford, PhD | |
| United States, South Carolina | |
| SleepMed | Recruiting |
| Columbia, South Carolina, United States, 29201 | |
| Contact: Richard Bogan, MD 803-251-3093 | |
| Principal Investigator: Richard Bogan, 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: | October 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013