Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IDE #G090014 | Other Identifier | FDA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant. |
|
| Control | Other | The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from Baseline to 6 Months |
| 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. | 12 months |
| Safety Analysis | Description of all adverse events | 12 months |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MidAmerica Neuroscience Research Institute | Lenexa | Kansas | 66214 | United States | ||
| Veritas Clinical Specialties |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Topeka |
| Kansas |
| 66606 |
| United States |
| Kentucky Research Group | Louisville | Kentucky | 40217 | United States |
| The Center for Sleep and Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| St. Lukes Hospital | St Louis | Missouri | 63017 | United States |
| Clinilabs | New York | New York | 10019 | United States |
| Wilmington Medical Research | Wilmington | North Carolina | 28401 | United States |
| Community Research | Cincinnati | Ohio | 45230 | United States |
| Sleep Med of South Carolina | Columbia | South Carolina | 29201 | United States |
| Sleep Therapy and Research Center | San Antonio | Texas | 78229 | United States |
| Westmead Hospital | Sydney | New South Wales | 2145 | Australia |
| IBAS, The Austin Hospital | Melbourne | Victoria | 3084 | Australia |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D001049 | Apnea |
| D012891 | Sleep Apnea Syndromes |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided