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

Phase 3

Terminated

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT01446601
• Lead Sponsor: Apnex Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-02
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Status Verified: 2011-12
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 132

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety Analysis	12 months	Description of all adverse events
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.

Trial Locations

Locations (14)

MidAmerica Neuroscience Research Institute; 🇺🇸 Lenexa, Kansas, United States

Veritas Clinical Specialties; 🇺🇸 Topeka, Kansas, United States

Kentucky Research Group; 🇺🇸 Louisville, Kentucky, United States

The Center for Sleep and Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

St. Lukes Hospital; 🇺🇸 St. Louis, Missouri, United States

Clinilabs; 🇺🇸 New York, New York, United States

Wilmington Medical Research; 🇺🇸 Wilmington, North Carolina, United States

Community Research; 🇺🇸 Cincinnati, Ohio, United States

Scroll for more (4 remaining)