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.

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