The role of oral appliances in the routine treatment of obstructive sl
eep apnea (OSA) is not well defined. This prospective study attempts t
o clarify the clinical role of a specific oral appliance, the mandibul
ar repositioning device (MRD). This study evaluated the demographic, p
olysomnographic, and cephalometric radiographic findings predictive of
treatment success or failure with the MRD. Twenty-nine patients were
diagnosed with mild to severe OSA by nocturnal polysomnography. The ma
jority of these patients were intolerant to nasal continuous positive
airway pressure (CPAP) and all were fitted with a MRD. Twenty-three of
these patients were compliant initially with MRD use and received pos
t-treatment nocturnal polysomnography at a mean of 104 days after rece
iving the device. The respiratory disturbance index (RDI) decreased wi
th MRD use (37 +/- 23 versus 18 +/- 20 events/hour, p < 0.001), and 16
of the 23 patients (16%) were considered responders (decrease in RDI
greater than or equal to 50% and posttreatment RDI less than or equal
to 20). Measurements of subjective and objective daytime sleepiness, n
octurnal oxygen desaturation, and snoring were all improved with MRD u
se. A pre-treatment RDI > 40 was present in four of the seven (67%) no
n-responders. Age, body mass index, and cephalometric radiographic mea
surements were not predictive of treatment outcome. Sixteen of 23 pati
ents (70%) continue to use the MRD after 3.4 +/- 0.7 years. This study
suggests that the MRD is useful in the long-term treatment of patient
s with OSA of mild to moderate severity.