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

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: HGNS Treatment

• Registration Number: NCT01186926
• Lead Sponsor: Apnex Medical, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2010-12
• Status Verified: 2011-12
• Study Completion: 2013-05
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HGNS Treatment	HGNS Treatment	-

Primary Outcome Measures

Name	Time	Method
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline	6 months post-implant
Adverse event profile interoperatively, perioperatively, and long term post implant	1, 3, 6, 12, 24, and 36 months post implant

Secondary Outcome Measures

Name	Time	Method
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline	6 months post-implant