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
  Purpose

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).


Condition Intervention Phase
Obstructive Sleep Apnea
Device: HGNS Treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Australian Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Apnex Medical, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: May 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HGNS Treatment 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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186926

Sponsors and Collaborators
Apnex Medical, Inc.
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Apnex Medical, Inc.
ClinicalTrials.gov Identifier: NCT01186926     History of Changes
Other Study ID Numbers: CLP-003
Study First Received: August 20, 2010
Last Updated: December 6, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Apnex Medical, Inc.:
Obstructive sleep apnea
OSA
hypoglossal nerve stimulation
sleep apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014