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

Stopped early · Phase 3

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT01446601

Run by

Apnex Medical, Inc.

People needed

132

Starts

2011-08-01

Expected to finish

2013-08-01

Last updated by the study team

2015-04-15

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Sleep Med of South Carolina — Columbia, South Carolina, United States
• Sleep Therapy and Research Center — San Antonio, Texas, United States
• Westmead Hospital — Sydney, New South Wales, Australia
• IBAS, The Austin Hospital — Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.