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

This study is currently recruiting participants.

Verified December 2011 by Apnex Medical, Inc.

Sponsor:

Information provided by (Responsible Party):

Apnex Medical, Inc.

ClinicalTrials.gov Identifier:

NCT01446601

First received: September 2, 2011

Last updated: December 6, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 2, 2011

Last Updated Date

December 6, 2011

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction in OSA Severity [ Time Frame: from Baseline to 6 Months ] [ Designated as safety issue: No ]
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
Long-term Reduction in OSA Severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Safety Analysis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Description of all adverse events

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01446601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Obstructive Sleep Apnea

Intervention ^ICMJE

Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )

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.

Study Arm (s)

Experimental: Treatment
The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.

Intervention: Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
Control
The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.

Intervention: Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

132

Estimated Completion Date

October 2017

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Linda J Johnson, PhD

651-757-4300 ext 1740

ljohnson@apnexmedical.com

Location Countries ^ICMJE

United States, Australia

Administrative Information

NCT Number ^ICMJE

NCT01446601

Other Study ID Numbers ^ICMJE

CLP-005, IDE #G090014

Has Data Monitoring Committee

Yes

Responsible Party

Apnex Medical, Inc.

Study Sponsor ^ICMJE

Apnex Medical, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Apnex Medical, Inc.

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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