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

Phase 3TerminatedNCT01446601

Apnex Medical, Inc.132 enrolled

Overview

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

132

Conditions

Obstructive Sleep Apnea

Interventions

Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )DEVICE

The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 21 to 80 years * Body mass index (BMI) ≤ 35 kg/m² * Previously diagnosed with Moderate to severe OSA * Individual has failed or does not tolerate PAP therapy

Locations (14)

MidAmerica Neuroscience Research Institute

Lenexa, Kansas, United States

Veritas Clinical Specialties

Topeka, Kansas, United States

Kentucky Research Group

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Reduction in OSA Severity

The proportion of subjects that experience clinically meaningful improvement in AH1 (reduction \>50% and AHI \<20) and ODI 4% (reduction \>= 25% or ODI 4% \<5)from Baseline to 6 Months will be significantly greater in the Treatment Group compared to the Control Group

Time frame: from Baseline to 6 Months

Long-term Reduction in OSA Severity

The proportion of subjects in the Treatment Group that experience clinically relevant improvement in AHI (reduction \>50% and AHI \<20) and ODI 4% (reduction \>=25% or ODI 4% \<5 at 12 months compared to Baseline.

Time frame: 12 months

Safety Analysis

Description of all adverse events

Time frame: 12 months

Data from ClinicalTrials.gov

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