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  • Title: The efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: a quasi-experimental study.
    Author: Alshhrani WM, Hamoda MM, Okuno K, Kohzuka Y, Fleetham JA, Ayas NT, Comey R, Almeida FR.
    Journal: J Clin Sleep Med; 2021 Aug 01; 17(8):1607-1618. PubMed ID: 33745505.
    Abstract:
    STUDY OBJECTIVES: To evaluate the short-term efficacy and self-reported outcomes of tongue-stabilizing device (TSD) therapy as compared to those of mandibular advancement device (MAD) therapy in an adult population diagnosed with obstructive sleep apnea. METHODS: This study is a parallel, nonrandomized clinical trial of the TSD and MAD therapies. The efficacy of both interventions was evaluated objectively by level 3 home sleep apnea testing and by self-report using the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire, the Chalder Fatigue Scale, and the 36-Item Short-Form Health Survey. Adherence and adverse effects were self-reported. RESULTS: Of the 39 patients who received TSD therapy, 27 managed to adapt and complete the trial and were matched with 26 patients who received MAD therapy. At the 2-month follow-up, the acceptance rate of the TSD therapy was 53.8%. Both patients receiving TSD therapy and patients receiving MAD therapy showed significant improvements in their respiratory event index (P < .05), with no difference between the treatments (P > .05). In those receiving TSD therapy (n = 27), the only self-reported efficacy measure that significantly improved with TSD therapy was the Chalder Fatigue Scale (P < .05). In contrast, all 4 self-reported measures (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, 36-Item Short-Form Health Survey, and Chalder Fatigue Scale) showed a significant improvement with MAD therapy. CONCLUSIONS: This study revealed similar improvements in apneas and oxygen saturation between TSD and MAD therapies. Whereas MAD therapy was a better treatment for obstructive sleep apnea in terms of daytime sleepiness and quality-of-life improvements, TSD therapy had a low treatment acceptance rate. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: The Efficacy of Tongue Stabilizing Device in Patients with Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT02329925; Identifier: NCT02329925; and Registry: ClinicalTrials.gov; Name: Adherence and Preference of Continuous Positive Airway Pressure vs Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial (CHOICE); URL: https://clinicaltrials.gov/ct2/show/NCT02242617; Identifier: NCT02242617. CITATION: Alshhrani WM, Hamoda MM, Okuno K, et al. The efficacy of a titrated tongue-stabilizing device on obstructive sleep apnea: a quasi-experimental study. J Clin Sleep Med. 2021;17(8):1607-1618.
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