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:
Apnex Medical, Inc.
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea |
Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pivotal 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:
- 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
| Estimated Enrollment: | 132 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant.
|
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.
|
|
Control
The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.
|
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.
|
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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: NCT01446601
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446601
Contacts
| Contact: Linda J Johnson, PhD | 651-757-4300 ext 1740 | ljohnson@apnexmedical.com |
Locations
| United States, Kansas | |
| MidAmerica Neuroscience Research Institute | Recruiting |
| Lenexa, Kansas, United States, 66214 | |
| Principal Investigator: Vernon D Rowe, MD | |
| Veritas Clinical Specialties | Recruiting |
| Topeka, Kansas, United States, 66606 | |
| Principal Investigator: William M Leeds, MD | |
| United States, Kentucky | |
| Kentucky Research Group | Recruiting |
| Louisville, Kentucky, United States, 40217 | |
| Principal Investigator: David H Winslow, MD | |
| United States, Maryland | |
| The Center for Sleep and Wake Disorders | Recruiting |
| Chevy Chase, Maryland, United States, 20815 | |
| Principal Investigator: Helene Emsellem, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Principal Investigator: Kathleen Yaremchuk, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55454 | |
| Principal Investigator: Con Iber, MD | |
| United States, Missouri | |
| St. Lukes Hospital | Recruiting |
| St. Louis, Missouri, United States, 63017 | |
| Principal Investigator: Paula Schweitzer, PhD | |
| United States, New York | |
| Clinilabs | Recruiting |
| New York, New York, United States, 10019 | |
| Principal Investigator: Mardik Donikyan, MD | |
| United States, North Carolina | |
| Wilmington Medical Research | Recruiting |
| Wilmington, North Carolina, United States, 28401 | |
| Principal Investigator: Mitchell D Lee, MD | |
| United States, Ohio | |
| Community Research | Recruiting |
| Cincinnati, Ohio, United States, 45230 | |
| Principal Investigator: James Maynard, MD | |
| United States, South Carolina | |
| Sleep Med of South Carolina | Recruiting |
| Columbia, South Carolina, United States, 29201 | |
| Principal Investigator: Richard Bogan, MD | |
| United States, Texas | |
| Sleep Therapy and Research Center | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: James M Andry, MD | |
| Australia, New South Wales | |
| Westmead Hospital | Recruiting |
| Sydney, New South Wales, Australia, 2145 | |
| Principal Investigator: John Wheatley, MD | |
| Australia, Victoria | |
| IBAS, The Austin Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3084 | |
| Principal Investigator: Maree Barnes, MBBS | |
Sponsors and Collaborators
Apnex Medical, Inc.
More Information
No publications provided
| Responsible Party: | Apnex Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01446601 History of Changes |
| Other Study ID Numbers: | CLP-005, IDE #G090014 |
| Study First Received: | September 2, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Apnex Medical, Inc.:
|
Apnea OSA Sleep Apnea Syndromes Sleep Apnea, Obstructive |
Hypoglossal Nerve Stimulation Sleep Disorders Tongue |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Dyssomnias Nervous System Diseases Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Disorders Sleep Disorders, Intrinsic |
ClinicalTrials.gov processed this record on February 26, 2015