Back to results

Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

HGNS Treatment

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, OSA, hypoglossal nerve stimulation, sleep apnea

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria

Previously diagnosed with moderate to severe obstructive sleep apnea.
Subject has failed or does not tolerate CPAP treatment.
Age between 21 and 70 years.
Body mass index (BMI) less than or equal to 40

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HGNS Treatment

Arm Description

Outcomes

Primary Outcome Measures

Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline

Adverse event profile interoperatively, perioperatively, and long term post implant

Secondary Outcome Measures

Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline

Full Information

NCT ID

NCT01186926

First Posted

August 20, 2010

Last Updated

April 14, 2015

Sponsor

Apnex Medical, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01186926

Brief Title

Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Apnex Medical, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea, OSA, hypoglossal nerve stimulation, sleep apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HGNS Treatment

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

HGNS Treatment

Intervention Description

The Apnex Hypoglossal Nerve Stimulation (HGNS) System 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.

Primary Outcome Measure Information:

Title

Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline

Time Frame

6 months post-implant

Title

Adverse event profile interoperatively, perioperatively, and long term post implant

Time Frame

1, 3, 6, 12, 24, and 36 months post implant

Secondary Outcome Measure Information:

Title

Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline

Time Frame

6 months post-implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria Previously diagnosed with moderate to severe obstructive sleep apnea. Subject has failed or does not tolerate CPAP treatment. Age between 21 and 70 years. Body mass index (BMI) less than or equal to 40

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maree Barnes, MD

Organizational Affiliation

Institute for Breathing and Sleep, Austin Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Hillman, MD

Organizational Affiliation

West Australian Sleep Disorders Research Institute, St. Charles Gardner Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Doug McEvoy, MD

Organizational Affiliation

Adelaide Institute for Sleep Health, Repatriation General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Wheatley, MD

Organizational Affiliation

Westmead Hospital Dept of Respiratory Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

22043118

Citation

Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011 Nov 1;34(11):1479-86. doi: 10.5665/sleep.1380.

Results Reference

result

Learn more about this trial

Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea

We'll reach out to this number within 24 hrs