Treatment efficacy of a titratable oral appliance in obstructive sleep apnea patients: a prospective clinical trial.
OBJECTIVE
This prospective clinical trial assessed the therapeutic outcomes of patients with obstructive sleep apnea (OSA) treated with a novel duobloc custom-made titratable mandibular advancement device (OAm).


METHODS
The modular Somnomed G2® OAm (Somnomed Europe AG, Zurich, Switzerland) with 'click-to-fit' adjustability provides instant feedback on the mandibular advancement. 161 consecutive patients with established diagnoses of OSA. Dental impressions were made and a bite registration in 75% of the maximal protrusion being the starting protrusion. Treatment response was defined as ≥ 50% decrease in apnea-hypopnea index (AHI). Treatment success was defined as 1a) AHI with OAm < 5 events/h sleep or 1b) AHI with OAm < 10 events/h. Treatment success and response were combined to define additional criteria: 2a) reduction in AHI ≥ 50% and AHI < 5 events/h; and 2b) reduction in AHI ≥ 50% and AHI <10 events/h.


RESULTS
In 112 patients AHI decreased significantly from 25 ± 18/h sleep at baseline to 12 ± 13/h with the OAm (p < 0.001). The visual analogue scoring for snoring (VAS) decreased significantly from 7 ± 3 to 2 ± 2 (p < 0.001). Treatment response was achieved in 65 of 112 patients (58%); 31% and 57% of patients were treated successfully according to criteria 1a and 1b, respectively. Furthermore, 31% and 50% of patients were treated successfully according to criteria 2a and 2b, respectively.


CONCLUSIONS
This clinical trial indicates that treatment with a novel custom-made OAm can reduce the severity of sleep-disordered breathing by significantly decreasing the AHI and VAS scores.
G
G
Van Haesendonck
M
M
Dieltjens
E
E
Hamans
M J
MJ
Braem
O M
OM
Vanderveken
D000328:Adult; D004864:Equipment and Supplies; D005260:Female; D006801:Humans; D008297:Male; D019186:Mandibular Advancement / Q000295:instrumentation*; D008875:Middle Aged; D017286:Polysomnography; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D012913:Snoring / Q000628:therapy*; D016896:Treatment Outcome