US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Sponsor
Apnex Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01211444
Collaborator
(none)
20
4
1
37
5
0.1
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
US Prospective Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Study Start Date
:
Jul 1, 2010
Actual Primary Completion Date
:
Aug 1, 2013
Actual Study Completion Date
:
Aug 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HGNS System
|
Device: HGNS Treatment
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.
|
Outcome Measures
Primary Outcome Measures
- Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline [6 months post-implant]
- Mean change in functional outcomes measured with the Functional Outcomes Sleep Questionnaire (FOSQ) compared to baseline [6 months post-implant]
- The frequency of serious adverse events. [One month post-implant.]
- The frequency of serious adverse events. [3 months post-implant.]
- The frequency of serious adverse events. [6 months post-implant.]
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California San Francisco | San Francisco | California | United States | 94143 |
| 2 | Saint Vincent Hospital | Indianapolis | Indiana | United States | 46260 |
| 3 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 4 | Clinilabs, Inc. | New York | New York | United States | 10019 |
Sponsors and Collaborators
- Apnex Medical, Inc.
Investigators
- Principal Investigator: Jon Freeman, PhD, Clinilabs, Inc. West Side ENT, NY, NY
- Principal Investigator: Tod Huntley, MD, Center for Ear, Nose, Throat and Allegery, PC (Centa), Carmel, IN
- Principal Investigator: Con Iber, MD, Dept of Neurology, University of Minnesota
- Principal Investigator: Eric Kezirian, MD, University of Califoprnia - San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Apnex Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01211444
Other Study ID Numbers:
- CLP-004
First Posted:
Sep 29, 2010
Last Update Posted:
Apr 15, 2015
Last Verified:
Oct 1, 2011
Keywords provided by Apnex Medical, Inc.
Additional relevant MeSH terms: