Waled M Alshhrani1,2, Mona M Hamoda1, Kentaro Okuno3, Yuuya Kohzuka4, John A Fleetham5, Najib T Ayas5, Robert Comey5, Fernanda R Almeida1. 1. Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia, Vancouver, British Columbia, Canada. 2. Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University, Riyadh, Saudi Arabia. 3. Department of Geriatric Dentistry, Osaka Dental University, Hirakata-shi, Japan. 4. Department of Perioperative Medicine, Division of Anesthesiology, Showa University School of Dentistry, Tokyo, Japan. 5. Division of Respiratory Medicine, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
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.
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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