Respiration Disorders, Signs and Symptoms, Respiratory, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Syndrome, Obstructive Sleep Apnea
Conditions
Keywords
Apnea, Respiration Disorders, Signs and Symptoms, Signs and Symptoms, Respiratory, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Tract Diseases, Sleep Disorders, Intrinsic, Sleep Disorders, Nervous System Diseases
Brief summary
The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
Interventions
DEVICEaura6000 THN System
The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.
Sponsors
ImThera Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AHI \>20 * Noncompliant to CPAP * Willing to provide informed consent * Willing to comply with all follow-up visits and evaluations
Exclusion criteria
* BMI limits * COPD * Central Sleep Apnea * Anatomic variations interfering with device placement or stability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Apnea-Hypopnea Index (AHI) | 3, 6, and 12 months post implant | Change from baseline in AHI measured through in-lab polysomnography (PSG). |
| Reduction in Oxygen Desaturation Index (ODI) | 3, 6, and 12 months post implant | Change from baseline in ODI measured through in-lab polysomnography (PSG). |
| Freedom from Serious Adverse Events (SAE) | 1 and 12 months post implant | Adverse events and Serious Adverse events post-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in sleep fragmentation | 3, 6, and 12 months post-implant | Mean change in microarousal index as compared to baseline. |
| Improvement in SAQLI | 3, 6, and 12 months post implant | Mean change in SAQLI (Sleep Apnea Quality of Life Index) as compared to baseline. |
| Improvement in ESS | 3, 6, and 12 months post implant | Mean change in ESS (Epworth Sleepiness Scale) as compared to baseline. |
Countries
Belgium, France, Germany, Italy, United States
Outcome results
None listed