Long term complications and Adverse effects associated with O2Vent Optima Oral Appliance and ExVent accessory in Obstructive Sleep Apnea Patients

Author(s): Sat Sharma, Antonella Conflitti, Hilary Reiter, Ivan Valcarenghi, Barry Weinstein, Shideh Pejman, Brian Smith, Adam Teo, Bob Gibbons

Introduction: The ExVent is an accessory to the O₂Vent Optima mandibular advancement device (MAD) and provides oral Expiratory Positive Airway Pressure (EPAP). Oral EPAP with the ExVent is designed to augment the OSA therapy provided by the O₂Vent Optima. Long term complications and adverse effects associated with this combination therapy are not known, but require further study.

Methods: A retrospective survey was conducted of all patients who received O₂Vent Optima MAD and ExVent in Canada and Australia since 2018. Data collected following consent included: demographics, duration of use, frequency of use, complications and adverse events.

Results: Out of the 480 subjects, 168 (35%) could be contacted and agreed to participate. 31 (18%) had stopped using the appliance. Out of 137 (81%) subjects, 118 (86%) were still using the ExVent Accessory, 92% medium strength (Yellow). 56% used morning aligner and 74% performed regular jaw exercises. After 4 weeks of the device use, excessive salivation was (12%, p<0.05), tooth and jaw pain were reported occasionally (8%, p<0.05), tooth movement was none (0%, p<0.05). Gum or tongue bruises (0%, p<0.05). TMJ pain/stiffness (5%, p<0.05). Change in bite or occlusion leading to discontinuation (0%, p<0.05), temporary chewing difficulties (24%, p<0.05) and dry mouth (0%, p<0.05). Difficulty to insert or remove ExVent valve (0%, p<0.05), difficulty breathing (0%, p<0.05), Malfunctioning or dislodgement of ExVent valve (0%, p<0.05). Participants reportedly valued their device (94%) and benefited with ExVent (100%).

Conclusion: Majority of the patients prescribed O₂Vent Optima and ExVent accessory were compliant, demonstrated no significant complications and only minor adverse effects with the combination therapy.