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

April 14, 2015 updated by: Apnex Medical, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • New York, New York, United States, 10019
        • Clinilabs, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Eligibility Criteria

  1. Previously diagnosed with moderate-to-severe obstructive sleep apnea.
  2. Subject has failed or does not tolerate CPAP treatment.
  3. Age between 21 and 70 years.
  4. Body mass index (BMI) less than or equal to 37.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HGNS System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Time Frame: 6 months post-implant
6 months post-implant
Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline
Time Frame: 6 months post-implant
6 months post-implant
The frequency of serious adverse events.
Time Frame: One month post-implant.
One month post-implant.
The frequency of serious adverse events.
Time Frame: 3 months post-implant.
3 months post-implant.
The frequency of serious adverse events.
Time Frame: 6 months post-implant.
6 months post-implant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apnex Medical, Inc.

Investigators

  • Principal Investigator: Jon Freeman, PhD, Clinilabs, Inc. West Side ENT, NY, NY
  • Principal Investigator: Tod Huntley, MD, Center for Ear, Nose, Throat and Allegery, PC (Centa), Carmel, IN
  • Principal Investigator: Con Iber, MD, Dept of Neurology, University of Minnesota
  • Principal Investigator: Eric Kezirian, MD, University of Califoprnia - San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (Estimate)

September 29, 2010

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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