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

Sponsor

Apnex Medical, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01446601

Collaborator

(none)

132

Enrollment

Locations

Arms

Duration (Months)

9.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.	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.
Other: Control The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.	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.

Arm

Intervention/Treatment

Experimental: Treatment

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

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.

Other: Control

The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.

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

Outcome Measures

Primary Outcome Measures

Reduction in OSA Severity [from Baseline to 6 Months]
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 [12 months]
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 [12 months]
Description of all adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MidAmerica Neuroscience Research Institute	Lenexa	Kansas	United States	66214
2	Veritas Clinical Specialties	Topeka	Kansas	United States	66606
3	Kentucky Research Group	Louisville	Kentucky	United States	40217
4	The Center for Sleep and Wake Disorders	Chevy Chase	Maryland	United States	20815
5	Henry Ford Hospital	Detroit	Michigan	United States	48202
6	University of Minnesota	Minneapolis	Minnesota	United States	55454
7	St. Lukes Hospital	St. Louis	Missouri	United States	63017
8	Clinilabs	New York	New York	United States	10019
9	Wilmington Medical Research	Wilmington	North Carolina	United States	28401
10	Community Research	Cincinnati	Ohio	United States	45230
11	Sleep Med of South Carolina	Columbia	South Carolina	United States	29201
12	Sleep Therapy and Research Center	San Antonio	Texas	United States	78229
13	Westmead Hospital	Sydney	New South Wales	Australia	2145
14	IBAS, The Austin Hospital	Melbourne	Victoria	Australia	3084