A pilot study on comparison of subjective titration versus remotely controlled mandibular positioning during polysomnography and drug-induced sleep endoscopy, to determine the effective protrusive position for mandibular advancement device therapy.

STUDY OBJECTIVES: The aim of this pilot study was to evaluate the clinical effectiveness of subjective titration versus objectively guided titration during polysomnography (PSG) and drug-induced sleep endoscopy (DISE) in mandibular advancement device (MAD) therapy for patients with obstructive sleep apnea (OSA). METHODS: In this pilot cross-over study, patients underwent three titration procedures in randomized order: (1) subjective titration, (2) PSG-guided titration using a remotely controlled mandibular positioner (RCMP) and (3) DISE-assisted titration using RCMP. After each titration procedure, patients used the MAD for 1 month at the targeted protrusion obtained according to the preceding titration procedure. For each procedure, a follow-up PSG was performed after 1 month of MAD use in order to evaluate the efficacy of the MAD. RESULTS: Ten patients were included in the study. Overall, no significant differences in targeted optimal protrusion compared to maximal comfortable protrusion among the three titration methods were observed. There was no significant difference in reduction in AHI. In this study, PSG titration correctly classified 50% of patients as 'responder'. A higher predictive accuracy was found for DISE titration with a sensitivity of 83.3% and a specificity of 100%. CONCLUSIONS: This pilot randomized cross-over trial showed no differences in optimal mandibular positioning and corresponding efficacy of MAD between subjective titration, DISE titration or PSG titration.

Correction to: Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial.

Following publication of the original article [1], the authors reported that Fig. 1 had not been corrected based on the reviewer's comments. The correct Fig. 1 is presented below.

Scoring of Hypersomnolence and Fatigue in Patients With Obstructive Sleep Apnea Treated With a Titratable Custom-Made Mandibular Advancement Device.

STUDY OBJECTIVES: The objective of this study was to measure fatigue and hypersomnolence in patients with obstructive sleep apnea (OSA) treated with a mandibular advancement device (MAD), using Epworth Sleepiness Scale (ESS) for hypersomnolence and Checklist Individual Strength questionnaire (CIS20R) for fatigue. METHODS: This was a single-center, prospective cohort study. A total of 58 patients with OSA filled out ESS and CIS20R questionnaires at baseline and after 3 months of MAD treatment. A total of 39 full datasets were collected. Statistical analysis for reliability of the questionnaires, comparison between baseline and 3-month follow-up, correlation between the changes in the values of the two questionnaires, and changes in apnea-hypopnea index (AHI) were performed. RESULTS: CIS20R showed excellent reliability in this patient group at baseline and 3-month follow-up (Cronbach α = .97), ESS showed a marginally good reliability (Cronbach α = .82). The CIS20R (82/140) expressed high levels of fatigue at baseline, and ESS showed a normal level of daytime sleepiness. AHI, ESS, and CIS20R were significantly reduced under MAD treatment. A significant correlation between ESS and CIS20R was observed. No significant correlation between any of the questionnaires and the change in AHI was found. CONCLUSIONS: The CIS20R questionnaire results showed a high level of fatigue in the patients with OSA, and the questionnaire can be used to evaluate changes in fatigue due to MAD treatment after 3 months. The ESS failed to show similar characteristics. Therefore, a combination of ESS for hypersomnolence with CIS20R for fatigue is proposed for the follow-up of patients with OSA treated with MAD.

Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial.

BACKGROUND: The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is called titration and is generally based on resolution of subjective symptoms like snoring and/or daytime sleepiness as a function of protrusion. An objective approach uses a remotely controlled mandibular positioner (RCMP) during a full-night polysomnography (PSG), in analogy with continuous positive airway pressure (CPAP) titration. More recently, the feasibility of RCMP use during drug-induced sleep endoscopy (DISE) titration was reported. METHODS: This randomized crossover trial will compare DISE-assisted titration to PSG-guided titration, as well as with the conventional subjective titration method. The primary outcome is the actual mandibular protrusive position found to be the most optimal for each tested titration procedure. Furthermore, the therapeutic efficacy will be compared among the different titration modalities using level 1 sleep studies. DISCUSSION: Currently, the optimal titration of MAD therapy is most often based on 'trial and error'. The conventional method relies on subjective improvement in symptoms, although this may not provide the most accurate indicator for efficient titration. Therefore, relying on objective criteria in the titration process should be advantageous. In analogy with CPAP, titration of the most optimal mandibular protrusion could be performed using RCMP during an overnight titration PSG. Recently, it was shown that titration under direct visualization of upper airway patency and collapsibility is feasible using the RCMP during DISE. However, no clinical results for such a procedure are as yet available. This study is the first to compare the most optimal mandibular protrusive position according to three titration procedures, as well as to compare the therapeutic efficacy of these titration methods. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03716648 . Registered on 23 October 2018.