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

Purpose

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	Intervention	Phase
Obstructive Sleep Apnea	Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Sleep Disorders

U.S. FDA Resources

Further study details as provided by Apnex Medical, Inc.:

Primary Outcome Measures:

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

Estimated Enrollment:	132
Study Start Date:	August 2011
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.

Arms

Assigned Interventions

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.

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.

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446601

Contacts

Contact: Linda J Johnson, PhD

651-757-4300 ext 1740

ljohnson@apnexmedical.com

Locations

United States, Kansas
MidAmerica Neuroscience Research Institute	Recruiting
Lenexa, Kansas, United States, 66214
Principal Investigator: Vernon D Rowe, MD
Veritas Clinical Specialties	Recruiting
Topeka, Kansas, United States, 66606
Principal Investigator: William M Leeds, MD
United States, Kentucky
Kentucky Research Group	Recruiting
Louisville, Kentucky, United States, 40217
Principal Investigator: David H Winslow, MD
United States, Maryland
The Center for Sleep and Wake Disorders	Recruiting
Chevy Chase, Maryland, United States, 20815
Principal Investigator: Helene Emsellem, MD
United States, Michigan
Henry Ford Hospital	Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Kathleen Yaremchuk, MD
United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55454
Principal Investigator: Con Iber, MD
United States, Missouri
St. Lukes Hospital	Recruiting
St. Louis, Missouri, United States, 63017
Principal Investigator: Paula Schweitzer, PhD
United States, New York
Clinilabs	Recruiting
New York, New York, United States, 10019
Principal Investigator: Mardik Donikyan, MD
United States, North Carolina
Wilmington Medical Research	Recruiting
Wilmington, North Carolina, United States, 28401
Principal Investigator: Mitchell D Lee, MD
United States, Ohio
Community Research	Recruiting
Cincinnati, Ohio, United States, 45230
Principal Investigator: James Maynard, MD
United States, South Carolina
Sleep Med of South Carolina	Recruiting
Columbia, South Carolina, United States, 29201
Principal Investigator: Richard Bogan, MD
United States, Texas
Sleep Therapy and Research Center	Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: James M Andry, MD
Australia, New South Wales
Westmead Hospital	Recruiting
Sydney, New South Wales, Australia, 2145
Principal Investigator: John Wheatley, MD
Australia, Victoria
IBAS, The Austin Hospital	Recruiting
Melbourne, Victoria, Australia, 3084
Principal Investigator: Maree Barnes, MBBS

Sponsors and Collaborators

Apnex Medical, Inc.

More Information

No publications provided

Responsible Party:	Apnex Medical, Inc.
ClinicalTrials.gov Identifier:	NCT01446601 History of Changes
Other Study ID Numbers:	CLP-005, IDE #G090014
Study First Received:	September 2, 2011
Last Updated:	December 6, 2011
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Apnex Medical, Inc.:

Apnea
OSA
Sleep Apnea Syndromes
Sleep Apnea, Obstructive

Hypoglossal Nerve Stimulation
Sleep Disorders
Tongue

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013