Suspended

UNMASKThe UNMASK Study: A Post-Market Longitudinal Observational Study of the WinxTM Sleep Therapy System for the Treatment of Obstructive Sleep Apnea (OSA)

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2012
See protocol details

Summary

Principal SponsorApniCure, Inc.
Study ContactLawrence Siegel, MDMore contacts
Last updated: September 4, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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).

NCT01683721
Principal SponsorApniCure, Inc.
Study ContactLawrence Siegel, MDMore contacts
Last updated: September 4, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Apnea, Obstructive

Criteria

3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

St. Petersburg Sleep Disorders Center

St. Petersburg, United StatesOpen St. Petersburg Sleep Disorders Center in Google Maps
Recruiting

Sleep Medicine Associates of Texas (SMAT)

Dallas, United States
Suspended2 Study Centers