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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Apnex Medical, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Apnex Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01186926
First received: August 20, 2010
Last updated: December 6, 2011
Last verified: December 2011

August 20, 2010
December 6, 2011
March 2009
December 2010   (final data collection date for primary outcome measure)
  • Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline [ Time Frame: 6 months post-implant ] [ Designated as safety issue: No ]
  • Adverse event profile interoperatively, perioperatively, and long term post implant [ Time Frame: 1, 3, 6, 12, 24, and 36 months post implant ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01186926 on ClinicalTrials.gov Archive Site
Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline [ Time Frame: 6 months post-implant ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
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.
Experimental: HGNS Treatment
Intervention: Device: HGNS Treatment
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.
 
Active, not recruiting
40
May 2013
December 2010   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01186926
CLP-003
Yes
Apnex Medical, Inc.
Apnex Medical, Inc.
Not Provided
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
Apnex Medical, Inc.
December 2011

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