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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01446601
• Other study ID #: CLP-005
• Secondary ID: IDE #G090014
• Status: Terminated
• Phase: Phase 3
• First received: September 2, 2011
• Last updated: April 14, 2015
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2011
• Source: Apnex Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 132
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Australia	IBAS, The Austin Hospital	Melbourne	Victoria
Australia	Westmead Hospital	Sydney	New South Wales
United States	The Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	Community Research	Cincinnati	Ohio
United States	Sleep Med of South Carolina	Columbia	South Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	MidAmerica Neuroscience Research Institute	Lenexa	Kansas
United States	Kentucky Research Group	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Clinilabs	New York	New York
United States	Sleep Therapy and Research Center	San Antonio	Texas
United States	St. Lukes Hospital	St. Louis	Missouri
United States	Veritas Clinical Specialties	Topeka	Kansas
United States	Wilmington Medical Research	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Apnex Medical, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in OSA Severity	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	from Baseline to 6 Months	No
Primary	Long-term Reduction in OSA Severity	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.	12 months	No
Primary	Safety Analysis	Description of all adverse events	12 months	Yes