A Phase 3 interventional study of Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) in Obstructive Sleep Apnea, sponsored by Apnex Medical, Inc.. Terminated at 14 sites in 2 countries. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-04-15.
Sponsored by Apnex Medical, Inc. · Phase 3, Interventional, and Treatment
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 132 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Apnex Medical, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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 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.
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
Time frame: 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.
Time frame: 12 months
Safety Analysis
Description of all adverse events
Time frame: 12 months
This study is terminated, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Apnex Medical, Inc.