Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
2 other identifiers
interventional
132
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2011
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedApril 15, 2015
December 1, 2011
2 years
September 2, 2011
April 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
Safety Analysis
Description of all adverse events
12 months
Study Arms (2)
Treatment
EXPERIMENTALThe Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.
Control
OTHERThe Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.
Interventions
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 Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
MidAmerica Neuroscience Research Institute
Lenexa, Kansas, 66214, United States
Veritas Clinical Specialties
Topeka, Kansas, 66606, United States
Kentucky Research Group
Louisville, Kentucky, 40217, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55454, United States
St. Lukes Hospital
St Louis, Missouri, 63017, United States
Clinilabs
New York, New York, 10019, United States
Wilmington Medical Research
Wilmington, North Carolina, 28401, United States
Community Research
Cincinnati, Ohio, 45230, United States
Sleep Med of South Carolina
Columbia, South Carolina, 29201, United States
Sleep Therapy and Research Center
San Antonio, Texas, 78229, United States
Westmead Hospital
Sydney, New South Wales, 2145, Australia
IBAS, The Austin Hospital
Melbourne, Victoria, 3084, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2011
First Posted
October 5, 2011
Study Start
August 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
April 15, 2015
Record last verified: 2011-12