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

PHASE3TerminatedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Obstructive Sleep Apnea
Interventions
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.

Trial Locations (14)

2145

Westmead Hospital, Sydney

3084

IBAS, The Austin Hospital, Melbourne

10019

Clinilabs, New York

20815

The Center for Sleep and Wake Disorders, Chevy Chase

28401

Wilmington Medical Research, Wilmington

29201

Sleep Med of South Carolina, Columbia

40217

Kentucky Research Group, Louisville

45230

Community Research, Cincinnati

48202

Henry Ford Hospital, Detroit

55454

University of Minnesota, Minneapolis

63017

St. Lukes Hospital, St Louis

66214

MidAmerica Neuroscience Research Institute, Lenexa

66606

Veritas Clinical Specialties, Topeka

78229

Sleep Therapy and Research Center, San Antonio

Sponsors
All Listed Sponsors
lead

Apnex Medical, Inc.

INDUSTRY

NCT01446601 - Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea | Biotech Hunter | Biotech Hunter