Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2009
Typical duration for phase_2
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
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 20, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedApril 15, 2015
December 1, 2011
1.8 years
August 20, 2010
April 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
6 months post-implant
Adverse event profile interoperatively, perioperatively, and long term post implant
1, 3, 6, 12, 24, and 36 months post implant
Secondary Outcomes (1)
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline
6 months post-implant
Study Arms (1)
HGNS Treatment
EXPERIMENTALInterventions
The Apnex Hypoglossal Nerve Stimulation (HGNS) System is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping, and off when the patient is awake.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Related Publications (1)
Eastwood PR, Barnes M, Walsh JH, Maddison KJ, Hee G, Schwartz AR, Smith PL, Malhotra A, McEvoy RD, Wheatley JR, O'Donoghue FJ, Rochford PD, Churchward T, Campbell MC, Palme CE, Robinson S, Goding GS, Eckert DJ, Jordan AS, Catcheside PG, Tyler L, Antic NA, Worsnop CJ, Kezirian EJ, Hillman DR. Treating obstructive sleep apnea with hypoglossal nerve stimulation. Sleep. 2011 Nov 1;34(11):1479-86. doi: 10.5665/sleep.1380.
PMID: 22043118RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maree Barnes, MD
Institute for Breathing and Sleep, Austin Health
- PRINCIPAL INVESTIGATOR
David Hillman, MD
West Australian Sleep Disorders Research Institute, St. Charles Gardner Hospital
- PRINCIPAL INVESTIGATOR
Doug McEvoy, MD
Adelaide Institute for Sleep Health, Repatriation General Hospital
- PRINCIPAL INVESTIGATOR
John Wheatley, MD
Westmead Hospital Dept of Respiratory Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2010
First Posted
August 23, 2010
Study Start
March 1, 2009
Primary Completion
December 1, 2010
Study Completion
May 1, 2013
Last Updated
April 15, 2015
Record last verified: 2011-12