Back to resultsUS Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HGNS Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, OSA, Hypoglossal nerve stimulation, Sleep apnea
Eligibility Criteria
Eligibility Criteria
- Previously diagnosed with moderate-to-severe obstructive sleep apnea.
- Subject has failed or does not tolerate CPAP treatment.
- Age between 21 and 70 years.
- Body mass index (BMI) less than or equal to 37.
Sites / Locations
- University of California San Francisco
- Saint Vincent Hospital
- University of Minnesota
- Clinilabs, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HGNS System
Arm Description
Outcomes
Primary Outcome Measures
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline
The frequency of serious adverse events.
The frequency of serious adverse events.
The frequency of serious adverse events.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01211444
Brief Title
US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Official Title
US Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (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 overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with Obstructive Sleep Apnea (OSA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, OSA, Hypoglossal nerve stimulation, Sleep apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HGNS System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
HGNS Treatment
Intervention Description
The Apnex Hypoglossal Nerve Stimulation System (HGNS) 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.
Primary Outcome Measure Information:
Title
Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline
Time Frame
6 months post-implant
Title
Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline
Time Frame
6 months post-implant
Title
The frequency of serious adverse events.
Time Frame
One month post-implant.
Title
The frequency of serious adverse events.
Time Frame
3 months post-implant.
Title
The frequency of serious adverse events.
Time Frame
6 months post-implant.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria
Previously diagnosed with moderate-to-severe obstructive sleep apnea.
Subject has failed or does not tolerate CPAP treatment.
Age between 21 and 70 years.
Body mass index (BMI) less than or equal to 37.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Freeman, PhD
Organizational Affiliation
Clinilabs, Inc. West Side ENT, NY, NY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tod Huntley, MD
Organizational Affiliation
Center for Ear, Nose, Throat and Allegery, PC (Centa), Carmel, IN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Con Iber, MD
Organizational Affiliation
Dept of Neurology, University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Kezirian, MD
Organizational Affiliation
University of Califoprnia - San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Saint Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Clinilabs, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
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