Dataset Information

Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial.

ABSTRACT:

Objectives

To compare the effects of two types of titratable mandibular advancement devices (MADs), namely MAD-H (allowing limited vertical opening) and MAD-S (allowing free vertical opening), on respiratory parameters and upper airway dimensions in patients with mild to moderate obstructive sleep apnea (OSA).

Materials and methods

Patients with mild to moderate OSA (5 ≤ apnea-hypopnea index (AHI) < 30 /h) were randomly assigned to two parallel MAD groups. All MADs were subjectively titrated according to a standardized protocol during a 3-month follow-up. Every patient underwent two polysomnographic recordings, and two cone beam computed tomography scans in supine position: one at baseline and another one after 3 months with the MAD in situ. The primary outcome variables were the AHI in supine position (AHI-supine) and the minimal cross-sectional area of the upper airway in supine position (CSAmin-supine).

Results

A total of 49 patients were recruited, and 31 patients (21 men and 10 women) with a mean (± SD) age of 48.5 (± 13.9) years and a mean AHI of 16.6 (± 6.7) /h completed the study. In the per-protocol analysis, there was no significant difference between MAD-H (n = 16) and MAD-S (n = 15) in their effects on AHI-supine (P = 0.14) and CSAmin-supine (P = 0.59). Similar results were found in the intention-to-treat analysis (P = 0.47 and 0.57, respectively).

Conclusions

Within the limitations of this study, we conclude that there is no significant difference in the effects of an MAD allowing limited vertical opening and an MAD allowing free vertical opening on respiratory parameters and upper airway dimensions in patients with mild to moderate OSA.

Clinical relevance

MADs allowing limited vertical opening and allowing free vertical opening have similar effects on respiratory parameters and upper airway dimensions in patients with mild to moderate OSA.

Trial registration

ClinicalTrials.gov Identifier: NCT02724865. https://clinicaltrials.gov/ct2/show/NCT02724865.

SUBMITTER: Shi X

PROVIDER: S-EPMC10160211 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial.

Shi Xiaoxin X Lobbezoo Frank F Chen Hui H Rosenmöller Boudewijn R A M BRAM Berkhout Erwin E de Lange Jan J Aarab Ghizlane G

Clinical oral investigations 20230317 5

<h4>Objectives</h4>To compare the effects of two types of titratable mandibular advancement devices (MADs), namely MAD-H (allowing limited vertical opening) and MAD-S (allowing free vertical opening), on respiratory parameters and upper airway dimensions in patients with mild to moderate obstructive sleep apnea (OSA).<h4>Materials and methods</h4>Patients with mild to moderate OSA (5 ≤ apnea-hypopnea index (AHI) < 30 /h) were randomly assigned to two parallel MAD groups. All MADs were subjective ...[more]

PMID: 36928350

Similar Datasets

Project description:ObjectiveA preliminary clinical evaluation of the efficacy, comfort, and adverse reactions of two mandibular advancement devices (MADs) in the treatment of Obstructive Sleep Apnea (OSA).MethodsForty patients with mild-to-severe OSA were recruited and randomly divided into two groups. They were treated with Shark-fin or Silensor MAD, respectively. Treatment efficacy was evaluated by home sleep apnea tests, the snoring scale, Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI). A comfort scale questionnaire was applied. Cone beam computed tomography (CBCT), cephalometric radiography, and intraoral scanning were made before and after 3-month treatment to detect temporomandibular joints (TMJ), dental and skeletal changes. All data were assessed as normal distributed and analyzed by t test. The significance level was defined as α = 0.05.ResultsThe effective rate, defined as a decrease in Respiratory Event Index (REI) to less than 5 events per hour or a decrease of more than 50%, was 70% in the Shark-fin MAD group and 50% in the Silensor MAD group. REI, lowest oxygen saturation and maximum apnea and hypoventilation time were significantly improved in Shark-fin MAD group (P < 0.01), and the proportion of non-rapid eye movement (REM) sleep stage 3 was higher than before use (P < 0.05), while only REI and lowest oxygen saturation were significantly improved in Silensor MAD group (P < 0.05). The loudness of snoring was significantly decreased after one day using Shark-fin MAD (P < 0.05), and further decreased after one month (P < 0.01). Conversely, Silensor MAD exhibited inferior efficacy in mitigating snoring compared to Shark-fin MAD. Upon wearing the Shark-fin MAD, ESS were significantly improved after one month and three months (P < 0.05), and PSQI improved after three months (P < 0.05). Additionally, the Shark-fin MAD group had a significantly better comfort score compared to the Silensor MAD group (P < 0.05). There was no significant difference in TMJ, dental and skeletal structures in the two groups before and after treatment (P > 0.05).ConclusionBoth two MADs were effective in reducing REI and increasing lowest oxygen saturation on OSA patients, and Shark-fin MAD has better improvement effect and faster onset of action. In addition, Shark-fin MAD was superior to Silensor MAD in improving snoring loudness, daytime sleepiness, sleep quality and wearing comfort. There were no significant dental or skeletal changes, and no alterations in occlusion or temporomandibular joint function in the short term.Trial registrationClinical Trials.gov Registration ID ChiCTR2400086628. Registered 08/07/ 2024-Retrospectively registered, https://register.Clinicaltrialsgov .

Dataset Information

Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial.

Objectives

Materials and methods

Results

Conclusions

Clinical relevance

Trial registration

Publications

Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets