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Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
This study has been terminated.
Sponsor:
Apnex Medical, Inc.
Information provided by (Responsible Party):
Apnex Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01446601
First received: September 2, 2011
Last updated: April 14, 2015
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 Intervention Model: Parallel Assignment Masking: Single (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 ]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 ]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 ]Description of all adverse events
| Estimated Enrollment: | 132 |
| Study Start Date: | August 2011 |
| Study Completion Date: | August 2013 |
| Primary Completion Date: | August 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Locations
| United States, Kansas | |
| MidAmerica Neuroscience Research Institute | |
| Lenexa, Kansas, United States, 66214 | |
| Veritas Clinical Specialties | |
| Topeka, Kansas, United States, 66606 | |
| United States, Kentucky | |
| Kentucky Research Group | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Maryland | |
| The Center for Sleep and Wake Disorders | |
| Chevy Chase, Maryland, United States, 20815 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55454 | |
| United States, Missouri | |
| St. Lukes Hospital | |
| St. Louis, Missouri, United States, 63017 | |
| United States, New York | |
| Clinilabs | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| Wilmington Medical Research | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, Ohio | |
| Community Research | |
| Cincinnati, Ohio, United States, 45230 | |
| United States, South Carolina | |
| Sleep Med of South Carolina | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| Sleep Therapy and Research Center | |
| San Antonio, Texas, United States, 78229 | |
| Australia, New South Wales | |
| Westmead Hospital | |
| Sydney, New South Wales, Australia, 2145 | |
| Australia, Victoria | |
| IBAS, The Austin Hospital | |
| Melbourne, Victoria, Australia, 3084 | |
Sponsors and Collaborators
Apnex Medical, Inc.
More Information
| Responsible Party: | Apnex Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01446601 History of Changes |
| Other Study ID Numbers: |
CLP-005 IDE #G090014 ( Other Identifier: FDA ) |
| Study First Received: | September 2, 2011 |
| Last Updated: | April 14, 2015 |
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 Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on August 18, 2017