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

Primary Purpose

Obstructive Sleep Apnea

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
Sponsored by
Apnex Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Apnea, OSA, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypoglossal Nerve Stimulation, Sleep Disorders, Tongue

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MidAmerica Neuroscience Research Institute
  • Veritas Clinical Specialties
  • Kentucky Research Group
  • The Center for Sleep and Wake Disorders
  • Henry Ford Hospital
  • University of Minnesota
  • St. Lukes Hospital
  • Clinilabs
  • Wilmington Medical Research
  • Community Research
  • Sleep Med of South Carolina
  • Sleep Therapy and Research Center
  • Westmead Hospital
  • IBAS, The Austin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment

Control

Arm Description

The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.

The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.

Outcomes

Primary Outcome Measures

Reduction in OSA Severity
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
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
Description of all adverse events

Secondary Outcome Measures

Full Information

First Posted
September 2, 2011
Last Updated
April 14, 2015
Sponsor
Apnex Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01446601
Brief Title
Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
Official Title
Pivotal 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
Terminated
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Apnea, OSA, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypoglossal Nerve Stimulation, Sleep Disorders, Tongue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.
Arm Title
Control
Arm Type
Other
Arm Description
The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.
Intervention Type
Device
Intervention Name(s)
Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in OSA Severity
Description
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
Time Frame
from Baseline to 6 Months
Title
Long-term Reduction in OSA Severity
Description
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.
Time Frame
12 months
Title
Safety Analysis
Description
Description of all adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MidAmerica Neuroscience Research Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Veritas Clinical Specialties
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
The Center for Sleep and Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
St. Lukes Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Clinilabs
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Wilmington Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
Sleep Med of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
IBAS, The Austin Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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