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

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://ichgcp.net/clinical-trials-registry/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://ichgcp.net/clinical-trials-registry/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.

Keywords: adverse effects; blood pressure; mandibular advancement device; obstructive sleep apnea; quality of life; tongue-stabilizing device.

© 2021 American Academy of Sleep Medicine.

Figures

Figure 1. TSD and titration accessories.

The TSD (A), the TSD with a 4-mm titration accessory (B), and the TSD with a 7-mm titration accessory (C). TSD = tongue-stabilizing device.

Figure 2. Timeline and number of patients who stopped using the TSD over the course of the trial.

TSD = tongue-stabilizing device.

Figure 3. MAD arm selection process.

BMI = body mass index, CFQ = Chalder Fatigue Scale, ESS = Epworth Sleepiness Scale, FOSQ-10 = Functional Outcomes of Sleep Questionnaire, HSAT = home sleep apnea testing, MAD = mandibular advancement device, RDI = respiratory disturbance index, SF-36v2 = 36-Item Short-Form Health Survey, version 2.

Figure 4. Individual and average REI data for patients using TSD and MAD.

MAD = mandibular advancement device, REI = respiratory event index, TSD = tongue-stabilizing device.