Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, OSA, hypoglossal nerve stimulation, sleep apnea
Brief summary
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).
Interventions
DEVICEHGNS Treatment
The Apnex Hypoglossal Nerve Stimulation (HGNS) System is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping, and off when the patient is awake.
Sponsors
Apnex Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria 1. Previously diagnosed with moderate to severe obstructive sleep apnea. 2. Subject has failed or does not tolerate CPAP treatment. 3. Age between 21 and 70 years. 4. Body mass index (BMI) less than or equal to 40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in AHI measured with in-lab nighttime polysomnography (PSG) compared to baseline | 6 months post-implant |
| Adverse event profile interoperatively, perioperatively, and long term post implant | 1, 3, 6, 12, 24, and 36 months post implant |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in functional outcomes measured with the Functional Outcomes of Sleep Questionnaire (FOSQ) compared to baseline | 6 months post-implant |
Outcome results
None listed