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UBC Theses and Dissertations

A clinical trial of titrated tongue stabilizing device therapy for obstructive sleep apnea : efficacy, quality of life, compliance, and side effects Alshhrani, Waled Mohammed

Abstract

Objectives: To determine the short-term efficacy and subjective outcomes of tongue stabilizing device (TSD) therapy; to compare to mandibular advancement device (MAD) therapy in an adult with obstructive sleep apnea (OSA); and to evaluate the long-term effectiveness, compliance, and side effects of the TSD. Methods: This thesis involves the analysis of a non-randomized trial followed by an observational study. In a quasi-experimental design, the efficacy of TSD and MAD interventions was evaluated based on the respiratory event index and subjectively evaluating sleepiness, quality of life (QoL) and fatigue. TSD users were then followed for 12- and 30-month periods after therapy insertion. Their compliance was self-reported, and the side effects were determined based on questionnaires and 3D model analysis. Results: Of 39 patients who received the TSD therapy, 27 who managed to complete the trial were matched with 26 patients who received the MAD therapy. At the 2-month and 30-month follow-ups, the acceptance rate of the TSD therapy amounted to 53.8% and 15.4%, respectively. TSD and MAD therapies demonstrated a significant improvement in efficacy based on the respiratory event index, with no significant differences between the two treatments. An objective measure of blood pressure showed a statistically significant difference between treatments, with an increase in blood pressure in TSD users compared to a decrease for MAD users. Furthermore, in TSD users, the only subjective outcome measure that significantly improved was the fatigue. In contrast, after the MAD therapy, subjective measures showed significant improvement in sleepiness, QoL and fatigue. At the 30-month follow-up, I observed a significant average improvement in TSD users in sleepiness compared to the baseline. The most frequently reported side effects with TSD therapy included mouth dryness and excessive salivation, and one subject appeared to have developed central sleep apnea. The results of 3D analysis revealed varying magnitudes and patterns of tooth movement associated with TSD. Conclusions: The studies demonstrated similar improvement in apnea/hypopnea events and oxygen saturation between TSD and MAD therapies. TSD therapy was found to be an inferior treatment in terms of daytime sleepiness, QoL improvements, blood pressure and acceptance rate.

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