Abstract
To investigate the predictive value of side effects on usage times during the initial titration phase of oral appliance therapy for sleep apnoea. The secondary objective was to assess the correlation between subjective and objective usage times. A total of 21 subjects diagnosed with sleep apnoea and a history of non-compliance with CPAP therapy were enrolled in the 4-week clinical study. Objective compliance was assessed through an intra-oral compliance monitor embedded in a Thornton Adjustable Positioner. Subjective compliance was evaluated through self-reporting and questionnaire for side effects. Excess salivation, xerostomia and tooth discomfort were the most common side effects (61%-67%). Noises (OR=10, 95% CI=0.85-117.02, P=0.067), jaw discomfort (OR=15, 95% CI=1.21-185.20, P=0.035) and gum discomfort (OR=8.86, 95% CI=1.0-∞, P=0.038) were highly predictive of non-compliance. Subjects with either "none" or "mild" side effects recorded a mean oral appliance usage time ≥5.5hours/night, while subjects reporting "severe" side effects recorded a mean usage time ≤4hours/night. The mean usage time was 5.49hours/night, with nightly compliance (defined as >4hours per night for 70% the nights per week) at 33%. Nonetheless, compliance increased from 26%-50% from week 1 to week 4. The subjective and objective usage times were highly correlated (r=0.81). There was a high correlation between subjective and objective compliance reporting data. Moderate/severe side effects had the greatest effect on compliance.
Published Version
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