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

Phase 2

Completed

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

• Registration Number: NCT01211444
• Lead Sponsor: Apnex Medical, Inc.

Brief Summary

The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Status Verified: 2011-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HGNS System	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
Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline	6 months post-implant
The frequency of serious adverse events.	6 months post-implant.

Trial Locations

Locations (4)

Saint Vincent Hospital; 🇺🇸 Indianapolis, Indiana, United States

Clinilabs, Inc.; 🇺🇸 New York, New York, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States