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

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).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HGNS Treatment

Device

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 outcomes

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

Time frame: 6 months post-implant
Adverse event profile interoperatively, perioperatively, and long term post implant

Time frame: 1, 3, 6, 12, 24, and 36 months post implant

Secondary outcomes

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

Time frame: 6 months post-implant

Sponsors and collaborators

Lead sponsor

Apnex Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2013
First posted: Aug 23, 2010
Registry last updated: Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed