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Reiterative Development and Evaluation Study of OSA Therapy System | Clinical Trials | Clareo Health

UNKNOWN

Reiterative Development and Evaluation Study of OSA Therapy System

A Multicenter, Prospective, Variable Duration, Reiterative Development and Evaluation Study of ApniCure's Therapy System(s) for the Treatment of Obstructive Sleep Apnea (OSA)

NCT01634074•ApniCure, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is between the ages of 18 and 80.
•2. Subject is fluent in English and understands the Study protocol and is willing and able to comply with Study requirements and sign the informed consent form.
•3. Subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower).

Exclusion Criteria

•1. Poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed.
•2. Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the ApniCure System (e.g. dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could be exacerbated by the Attune Sleep Apnea System.
•3. History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery (MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
•4. Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep apnea.
•5. Currently working nights, or rotating night shifts.
•6. Current disease state, use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study.
•7. Female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.

Locations (7)

Penninsula Sleep Center (PSC)

Burlingame, California, United States

ApniCure, Inc.

Redwood City, California, United States

Sleep Disorders Center of Georgia (SDCG)

Atlanta, Georgia, United States

Kentucky Research Group

Louisville, Kentucky, United States

The Center for Sleep & Wake Disorders

Chevy Chase, Maryland, United States

SleepMed

Columbia, South Carolina, United States

Sleep Medicine Associates of Texas (SMAT)

Dallas, Texas, United States

Key Dates

Start Date

July 1, 2012

Primary Completion Date

July 1, 2014

Completion Date

July 1, 2014

Last Updated

November 25, 2013

Enrollment

150

ESTIMATED participants

Conditions

Obstructive Sleep Apnea

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

NCT06430957

Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

View study

RECRUITINGNA

Digital-supported Orofacial Myofunctional Therapy in OSA

NCT07292922

Obstructive Sleep Apnea (OSA)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Reiterative Development and Evaluation Study of OSA Therapy System

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea

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BodySleep Algorithm for OSA Diagnosis in Children