The efficacy of a titrated tongue stabilizing device on obstructive sleep apnea: a quasi-experimental study.

Abstract

STUDY OBJECTIVES\nTo evaluate short-term efficacy and subjective outcomes of TSD therapy as compared to those of mandibular advancement device (MAD) therapy in an adult population diagnosed with OSA.\n\n\nMETHODS\nThis study is a parallel, non-randomized clinical trial of the TSD and MAD therapies. The efficacy of both interventions was evaluated objectively by level 3 home sleep testing and subjectively, with the Epworth Sleepiness Scale (ESS), Functional Outcomes Sleep Questionnaire (FOSQ-10), Chalder Fatigue Scale (CFQ), and the sleep-related quality of life questionnaire (SF-36). Compliance and adverse effects were self-reported.\n\n\nRESULTS\nOf the 39 patients who received the TSD therapy, 27 managed to adapt and complete the trial and were matched with 26 patients who received the MAD therapy. At the two-month follow-up, the acceptance rate of the TSD therapy was 53.8%. Both the TSD and MAD patients demonstrated significant improvements in their respiratory event index, REI (p < 0.05), with no difference between the treatments (p > 0.05). In the TSD users (n = 27), the only subjective efficacy measure that significantly improved with the TSD use was CFQ (p < 0.05). In contrast, all four subjective measures (ESS, FOSQ-10, SF-36, and CFQ) showed a significant improvement with the MAD therapy.\n\n\nCONCLUSIONS\nThis study revealed similar improvements in apneas and oxygen saturation between the TSD and MAD therapies. The MAD therapy was a better treatment for OSA in terms of daytime sleepiness and QOL improvements, while TSD therapy had a low treatment acceptance rate.\n\n\nCLINICAL TRIAL REGISTRATION\nRegistry: ClinicalTrials.gov; The Efficacy of Tongue Stabilizing Device in Patients with Obstructive Sleep Apnea, Identifier: NCT02329925 and Adherence and Preference of Continuous Positive Airway Pressure Versus Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial (CHOICE), Identifier: NCT02242617.