Treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation - The OSPREY Study (LNS005)
Multi-center, open-label, prospective, randomized trial of the aura6000 system in adults patients with moderate to severe obstructive sleep apnea who have failed other treatments. Primary objective includes demonstrating safety and effectiveness of the aura6000 system after 6 months of stimulation when compared to a control group with no stimulation.
The study involves up to 18 visits over a 16-month period. The study is broken into 4 parts:1.Screening: Participants visit the research center to review health history and answer questions. During this time, a few sleep studies are done to make sure this is the right option.2.Implant: During a same-day outpatient procedure, the aura6000® device is implanted beneath the skin.3.Group Assignment: Participants are randomly assigned into one of two groups. Group 1 will have the device turned on after 1 month, whereas Group 2 will have the device turned on after 7 months4.Follow Up: Participants visit the research center and sleep lab regularly for overnight sleep tests. These visits allow the study team to program the device and see if the implant is helping. There are also questionnaires that participants fill out to measure sleep quality.
Willing and capable of using the remote control and charger to activate the therapy and charge the implant, complete all questionnaires, return for all follow-up evaluations and sleep studies for the duration of the study.
A documented diagnosis of moderate to severe OSA with an AHI of at least 15 using the AASM guideline for scoring hypopneas based a nasal pressure drop of 30% or greater and a desaturation of 4%.
Declines to use or does not tolerate PAP therapy.
No difficulty with sleeping in unfamiliar environments and can do so without the use of drugs or medications.
Dependent on or frequently taking medications (such as opioids, narcotics, or stimulants) that significantly alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness.
Moderate to severe (or poorly controlled) respiratory disease (e.g. COPD such as emphysema, TB, chest wall disease, uncontrolled asthma, allergic rhinitis, etc.), or is on supplemental oxygen therapy to control the respiratory disease.
One of the following: moderate to severe heart failure or a history of persistent atrial fibrillation, unstable angina, recent history of MI (<6m), severe cardiac arrhythmias, or uncontrolled systemic or pulmonary hypertension.
Neurological, neuromuscular, or neurodegenerative disorders; Other sleep disorders (narcolepsy, insomnia, RLS, PLMS); Active psychiatric condition that might interfere with the patient's compliance with the protocol, or effect the endpoints' assessment.