OPAP...

Patients who are unable to be compliant with a nasal mask due to claustrophobia, head aches due to chinstraps or head gear and complaints of mask leaks leading to eye irritation, sinusitis may benefit by using oral mask ventilation with the OPA P. Oral positive air pressure delivered by a newly conceived proprietary dental appliance (OPA P) is a treatment alternative to nasally applied positive air pressure (CPAP or BiPAP). Mandibular advancement and modification of the upper airway structures is thought to enlarge the airway or reduce its collapsibility.

The OPAP® is an oral appliance which incorporates an airway and mandibular position in its design and function. Lt assures an airway to the retropharynx during sleep and allows delivery of positive air pressure (CPAP or BiPAP) through it if needed. The combination of mandibular positioning and the creation of an airway allows for an alternative mode of treatment for the collapsible airway found in O SA patients. This type of dental appliance may be
used for mild to severe cases of OSA.

Evaluation of the patient for the suitability of an oral appliance from a medical and dental standpoint is first determined. A referral to a dental sleep specialist is then made. A complete dental exam including panorex, cephalometrics in addition to sonography of the TMJ joint was obtained prior to taking dental impressions may be considered. A bite registration is then obtained, allowing the OPAP® appliance to be custom made to the patients dental impressions. Once a comfortable fit is obtained the OPAP® was connected to CPAP or BiPAP by the standard tubing. A titration polysomnogram test is then recommended with the O PAP and positive air pressure.

Primary complaints with the OPAP® included oral drying, excessive salivation, discomfort with exhaling against CPAP. Drying improves with the use of an inline humidifier. Excessive salivation improved with adaptation and continued use of the oral appliance. Discomfort with exhalation against orally delivered CPAP improved with the use of orally delivered BiPAP. The OPAP® has been designed for patients with and without teeth­

Data presented to the FDA demonstrated the OPAP® appliance delivered oral air pressure capable of producing a reduction of the AHl in mild to severe cases of OSA to the same level of efficacy as nasal mask delivery. This type of dental appliance may serve to be a therapeutic alterative to nasal CPAP and in certain mild cases this oral appliance is by itself capable of treating mild OSA.

FDA Approval:
Date of FDA Approval: Oct. 18,1999
Date of Canadian Approval: Feb. 25, 1999
FDA Registration Number: K991926
Canadian Approval Number: 18949