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Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Apnex Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
Apnex Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01446601
First received: September 2, 2011
Last updated: December 6, 2011
Last verified: December 2011

September 2, 2011
December 6, 2011
August 2011
October 2013   (final data collection date for primary outcome measure)
  • Reduction in OSA Severity [ Time Frame: from Baseline to 6 Months ] [ Designated as safety issue: No ]
    The proportion of subjects that experience clinically meaningful improvement in AH1 (reduction >50% and AHI <20) and ODI 4% (reduction >= 25% or ODI 4% <5)from Baseline to 6 Months will be significantly greater in the Treatment Group compared to the Control Group
  • Long-term Reduction in OSA Severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The proportion of subjects in the Treatment Group that experience clinically relevant improvement in AHI (reduction >50% and AHI <20) and ODI 4% (reduction >=25% or ODI 4% <5 at 12 months compared to Baseline.
  • Safety Analysis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Description of all adverse events
Same as current
Complete list of historical versions of study NCT01446601 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea
Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.
  • Experimental: Treatment
    The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.
    Intervention: Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
  • Control
    The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.
    Intervention: Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
October 2017
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 21 to 80 years
  • Body mass index (BMI) ≤ 35 kg/m²
  • Previously diagnosed with Moderate to severe OSA
  • Individual has failed or does not tolerate PAP therapy
Both
21 Years to 80 Years
No
Contact: Linda J Johnson, PhD 651-757-4300 ext 1740 ljohnson@apnexmedical.com
United States,   Australia
 
NCT01446601
CLP-005, IDE #G090014
Yes
Apnex Medical, Inc.
Apnex Medical, Inc.
Not Provided
Not Provided
Apnex Medical, Inc.
December 2011

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