Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HGNS Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, OSA, hypoglossal nerve stimulation, sleep apnea
Eligibility Criteria
Eligibility Criteria
- Previously diagnosed with moderate to severe obstructive sleep apnea.
- Subject has failed or does not tolerate CPAP treatment.
- Age between 21 and 70 years.
- Body mass index (BMI) less than or equal to 40
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HGNS Treatment
Arm Description
Outcomes
Primary Outcome Measures
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Adverse event profile interoperatively, perioperatively, and long term post implant
Secondary Outcome Measures
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01186926
Brief Title
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
Official Title
Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apnex Medical, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea, OSA, hypoglossal nerve stimulation, sleep apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HGNS Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HGNS Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Time Frame
6 months post-implant
Title
Adverse event profile interoperatively, perioperatively, and long term post implant
Time Frame
1, 3, 6, 12, 24, and 36 months post implant
Secondary Outcome Measure Information:
Title
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline
Time Frame
6 months post-implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria
Previously diagnosed with moderate to severe obstructive sleep apnea.
Subject has failed or does not tolerate CPAP treatment.
Age between 21 and 70 years.
Body mass index (BMI) less than or equal to 40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maree Barnes, MD
Organizational Affiliation
Institute for Breathing and Sleep, Austin Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Hillman, MD
Organizational Affiliation
West Australian Sleep Disorders Research Institute, St. Charles Gardner Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doug McEvoy, MD
Organizational Affiliation
Adelaide Institute for Sleep Health, Repatriation General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Wheatley, MD
Organizational Affiliation
Westmead Hospital Dept of Respiratory Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22043118
Citation
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.
Results Reference
result
Learn more about this trial
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
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