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

NCT ID: NCT01683721

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Winx

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ApniCure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Petersburg Sleep Disorders Center

St. Petersburg, Florida, United States

Site Status RECRUITING

Sleep Medicine Associates of Texas (SMAT)

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lawrence Siegel, MD

Role: CONTACT

Phone: 650-361-9399

Email: [email protected]

Facility Contacts

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Role: primary

Philip Becker, MD

Role: primary

Other Identifiers

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12023

Identifier Type: -

Identifier Source: org_study_id