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Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01186926
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):
Apnex Medical, Inc.

Tracking Information
First Submitted Date  ICMJE August 20, 2010
First Posted Date  ICMJE August 23, 2010
Last Update Posted Date April 15, 2015
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
  • Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline [ Time Frame: 6 months post-implant ]
  • Adverse event profile interoperatively, perioperatively, and long term post implant [ Time Frame: 1, 3, 6, 12, 24, and 36 months post implant ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2010)
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline [ Time Frame: 6 months post-implant ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
Official Title  ICMJE Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE Device: HGNS Treatment
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.
Study Arms  ICMJE Experimental: HGNS Treatment
Intervention: Device: HGNS Treatment
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 20, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Eligibility Criteria

  1. Previously diagnosed with moderate to severe obstructive sleep apnea.
  2. Subject has failed or does not tolerate CPAP treatment.
  3. Age between 21 and 70 years.
  4. Body mass index (BMI) less than or equal to 40
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01186926
Other Study ID Numbers  ICMJE CLP-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Apnex Medical, Inc.
Study Sponsor  ICMJE Apnex Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Apnex Medical, Inc.
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP