Respiration Disorders, Signs and Symptoms, Respiratory, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Syndrome, Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, neurostimulation, hypoglossal nerve
Brief summary
The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
Interventions
DEVICEaura6000 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
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe obstructive sleep apnea (AHI 15 to 60). * Cannot or will not tolerate CPAP treatment. * Body mass index (BMI) between 25 and 40 * Able to read, understand, sign and date the written informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in AHI measured through in-lab polysomnography (PSG) compared to baseline. | 3 and 12 months post-implant |
| Adverse events and Serious Adverse events peri and post-operatively | 3 and 12 months post-operative |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Quality of Life outcomes measured with ESS (Epworth Sleepiness Scale) as compared to baseline. | 3 and 12 months post-operative |
| Mean change in Quality of Life outcomes measured with FSS (Fatigue Severity Scale) as compared to baseline. | 3 and 12 months post-implantation |
Countries
Belgium
Outcome results
None listed