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

Apnex Medical, Inc.40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

HGNS TreatmentDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 40

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.