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US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

NCT01211444 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-15

No results posted yet for this study

Summary

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).

Conditions

Interventions

DEVICE

HGNS Treatment

The Apnex Hypoglossal Nerve Stimulation System (HGNS) is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping and off when the patient is awake.

Sponsors & Collaborators

  • Apnex Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Jon Freeman, PhD · Clinilabs, Inc. West Side ENT, NY, NY

  • Tod Huntley, MD · Center for Ear, Nose, Throat and Allegery, PC (Centa), Carmel, IN

  • Con Iber, MD · Dept of Neurology, University of Minnesota

  • Eric Kezirian, MD · University of Califoprnia - San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01211444 on ClinicalTrials.gov