Use of the ExVent Accessory With the O2Vent Optima Oral Appliance for the Treatment of Obstructive Sleep Apnea
Sleep Apnea, Obstructive, Sleep-Disordered Breathing
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Sleep apnea, MAD, positive expiratory pressure
Eligibility Criteria
Inclusion Criteria: Male or female subject aged 22 years or older. Subject completed a PSG study within the last 6 months at the investigational site's sleep lab and obtained a baseline AHI confirming a diagnosis of mild to moderate obstructive sleep apnea. Subject (self-reports) that he/she is currently a compliant O2Vent Optima user (i.e., using the device for at least 4 hours/night for at least 5 nights/week). Subject completed initial fitting optimization of the O2Vent Optima device. Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days. Must be able to comply with all study requirements as outlined in the protocol. Exclusion Criteria: Inclusion Criteria: Male or female subject aged 22 years or older. Subject completed a PSG study within the last 6 months at the investigational site's sleep lab and obtained a baseline AHI confirming a diagnosis of mild to moderate obstructive sleep apnea. Subject (self-reports) that he/she is currently a compliant O2Vent Optima user (i.e., using the device for at least 4 hours/night for at least 5 nights/week). Subject completed initial fitting optimization of the O2Vent Optima device. Investigator has determined that the subject could abstain from use of the oral appliance or other sleep apnea therapies for up to 7 days. Must be able to comply with all study requirements as outlined in the protocol. Exclusion Criteria: Oral cavity infection or any other oral or dental condition or problem that would limit patient use of the O2Vent Optima oral appliance. Any concomitant diagnosed or suspected sleep disorder including insomnia or central apnea. History of any prior OSA surgical treatments including RF ablation treatment or palatal stent devices. Concomitant use of any other prescription device for treatment of OSA. Female of child-bearing age who is pregnant or intending to become pregnant during the study participation period. Subject with significant change in weight since completion of the diagnostic baseline PSG study (i.e., ±10% or greater change in total body weight. Subject on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics). Subject who consumes > 500 mg caffeine per day (e.g., > 8 cola-type beverages, > 5 cups of coffee). Subject who consumes > 3 alcoholic drinks/day. Subject currently enrolled in any other research study.
Sites / Locations
- Centre for Sleep and ChronobiologyRecruiting
Arms of the Study
Arm 1
Other
Single arm
Prospective, open label, single-arm multicenter study