Dataset Information

Efficacy of Oral Appliance Therapy as a First-Line Treatment for Moderate or Severe Obstructive Sleep Apnea: A Korean Prospective Multicenter Observational Study.

ABSTRACT: BACKGROUND AND PURPOSE:Responses to oral appliances (OAs) in obstructive sleep apnea (OSA) vary, and have not been fully evaluated in Korean patients. In this study we aimed to determine the efficacy of OAs for the first-line treatment of Korean patients with moderate or severe OSA. METHODS:This multicenter prospective observational study included 45 patients with moderate or severe OSA that had been newly diagnosed between March 2017 and May 2018 and who underwent OA treatment for 1 month. Questionnaires were completed and polysomnography (PSG) was performed before and after OA treatment. The primary outcome measures were improvement in the absolute apnea-hypopnea index (AHI) and the percentage reduction in the AHI. The secondary outcomes were improvements in the questionnaire scores related to sleep-associated symptoms and PSG parameters. RESULTS:The patients were aged 47.4±12.1 years (mean±SD), only two of them were female, and their AHI at baseline was 29.7±10.9/h. After OA treatment the AHI had reduced by 63.9±25.8%, with the reduction was similar between the patients with moderate OSA and those with severe OSA. Overall 31.1% of the patients achieved a normal AHI (<5/h), and 64.4% had an AHI of ?10/h after the treatment. The body mass index (BMI) was the most reliable factor for predicting the percentage reduction in the AHI. The OAs also improved the sleep architecture and subjective sleep-related symptoms. CONCLUSIONS:The OAs were effective in patients with moderate or severe OSA. The OAs reduced the mean AHI to 63.9% of the baseline value, and this reduction was influenced by the BMI.

SUBMITTER: Byun JI

PROVIDER: S-EPMC7174116 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Efficacy of Oral Appliance Therapy as a First-Line Treatment for Moderate or Severe Obstructive Sleep Apnea: A Korean Prospective Multicenter Observational Study.

Byun Jung Ick JI Kim Dongha D Ahn Su Jin SJ Yang Kwang Ik KI Cho Yong Won YW Cistulli Peter A PA Shin Won Chul WC

Journal of clinical neurology (Seoul, Korea) 20200401 2

<h4>Background and purpose</h4>Responses to oral appliances (OAs) in obstructive sleep apnea (OSA) vary, and have not been fully evaluated in Korean patients. In this study we aimed to determine the efficacy of OAs for the first-line treatment of Korean patients with moderate or severe OSA.<h4>Methods</h4>This multicenter prospective observational study included 45 patients with moderate or severe OSA that had been newly diagnosed between March 2017 and May 2018 and who underwent OA treatment fo ...[more]

PMID: 32319237

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Project description:Study objectivesOral appliance therapy has emerged as an important alternative to continuous positive airway pressure (CPAP) in treating patients with obstructive sleep apnea syndrome (OSAS). In this study we report about the subjective and objective treatment outcome of oral appliance therapy and CPAP in patients with OSAS.DesignCohort study of a previously conducted randomized clinical trial.SettingUniversity Medical Center, Groningen, The Netherlands.Patients or participantsOne hundred three patients with OSAS.InterventionsCPAP and oral appliance therapy (Thornton Adjustable Positioner type-1, Airway Management, Inc., Dallas, TX, USA).Measurements and resultsObjective (polysomnography) and subjective (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Medical Outcomes Study 36-item Short Form Health Survey [SF-36]) parameters were assessed after 1 and 2 years of treatment. Treatment was considered successful when the apnea-hypopnea index (AHI) was < 5 or showed substantial reduction, defined as reduction in the index of at least 50% from the baseline value to a value of < 20 in a patient without OSAS symptoms while undergoing therapy. Regarding the proportions of successful treatments, no significant difference was found between oral appliance therapy and CPAP in treating mild to severe OSAS in a 2-year follow-up. More patients (not significant) dropped out under oral appliance therapy (47%) compared with CPAP (33%). Both therapies showed substantial improvements in polysomnographic and neurobehavioral outcomes. However, CPAP was more effective in lowering the AHI and showed higher oxyhemoglobin saturation levels compared to oral appliance therapy (P < 0.05).ConclusionsOral appliance therapy should be considered as a viable treatment alternative to continuous positive airway pressure (CPAP) in patients with mild to moderate obstructive sleep apnea syndrome (OSAS). In patients with severe OSAS, CPAP remains the treatment of first choice.Clinical trial informationThe original randomized clinical trial, of which this study is a 2-year follow-up, is registered at ISRCTN.org; identifier: ISRCTN18174167; trial name: Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy; URL: http://www.controlled-trials.com/ISRCTN18174167.

Project description:Study objectivesThe review aimed to identify the factors influencing adherence to oral appliance therapy in adults with obstructive sleep apnea.MethodsThe protocol was initially registered with the International Register of Systematic Reviews (Prospero: CRD42019122615) prior to undertaking a comprehensive electronic search of databases and references without language and date restrictions. Quality assessment was undertaken using the Cochrane Collaboration's risk of bias tool and Quality in Prognosis Studies (QUIPS) tool.ResultsStudies exhibited low or unclear risk of bias for the domains assessed by the respective quality assessment tools. The influence of independent variables such as disease characteristics, patient characteristics, appliance features, and psychological and social factors on adherence levels was also assessed. There was a total of 31 included studies, which consisted of 8 randomized controlled trials, 2 controlled clinical trial, 7 prospective cohorts, 11 retrospective cohorts, and the remaining 3 studies were a case-series, case-control, and a mixed-methods. All 31 included studies were subject to qualitative analysis, with only 4 studies included in the quantitative analysis. Results of the meta-analysis demonstrated increased adherence with custom-made appliances, with a pooled mean difference of -1.34 (-2.02 to -0.66) and low levels of heterogeneity (I² = 0%).ConclusionsA weak relationship was observed between objective adherence and patient and disease characteristics, such as age, sex, obesity, apnea-hypopnea index, and daytime sleepiness, to oral appliance therapy. Nonadherent patients reported more side effects with oral appliance therapy than users and tended to discontinue the treatment within the first 3 months. Custom-made oral appliances were preferred and increased adherence reported in comparison to ready-made appliances. Further research is imperative to examine the relationship between psychosocial factors and adherence to oral appliance therapy.

Project description:Study objectivesOral appliance therapy is not commonly used to treat obstructive sleep apnea due to inconsistent efficacy and lack of established configuration procedures. Both problems may be overcome by information gathered while repositioning the mandible during sleep. The purpose of this investigation was to determine if an unattended sleep study with a mandibular positioner can predict therapeutic success and efficacious mandibular position, assess the contribution of artificial intelligence analytics to such a system, and evaluate symptom resolution using an objective titration approach.MethodsFifty-eight individuals with obstructive sleep apnea underwent an unattended sleep study with an auto-adjusting mandibular positioner followed by fitting of a custom oral appliance. Therapeutic outcome was assessed by the 4% oxygen desaturation index with therapeutic success defined as oxygen desaturation index < 10 h-1. Outcome was prospectively predicted by an artificial intelligence system and a heuristic, rule-based method. An efficacious mandibular position was also prospectively predicted by the test. Data on obstructive sleep apnea symptom resolution were collected 6 months following initiation of oral appliance therapy.ResultsThe artificial intelligence method had significantly higher predictive accuracy (sensitivity: 0.91, specificity: 1.00) than the heuristic method (P = .016). The predicted efficacious mandibular position was associated with therapeutic success in 83% of responders. Appliances titrated based on oxygen desaturation index effectively resolved obstructive sleep apnea symptoms.ConclusionsThe MATRx plus device provides an accurate means for predicting outcome to oral appliance therapy in the home environment and offers a replacement to blind titration of oral appliances.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: Predictive Accuracy of MATRx plus in Identifying Favorable Candidates for Oral Appliance Therapy; Identifier: NCT03217383; URL: https://clinicaltrials.gov/ct2/show/NCT03217383.CitationMosca EV, Bruehlmann S, Zouboules SM, et al. In-home mandibular repositioning during sleep using MATRx plus predicts outcome and efficacious positioning for oral appliance treatment of obstructive sleep apnea. J Clin Sleep Med. 2022;18(3):911-919.

Project description:We aimed to evaluate the impact of a novel noninvasive oral pressure therapy (OPT) (Winx®, ApniCure) system on polysomnographic measures of sleep-disordered breathing, sleep architecture, and sleep stability in obstructive sleep apnea (OSA).A 4-week, multicenter, prospective, open-label, randomized, crossover, first-night order of control vs treatment, single-arm trial was conducted in five American Academy of Sleep Medicine (AASM) - accredited sleep clinics and one research laboratory. Sixty-three subjects (analysis cohort) were studied from a screening cohort of 367 subjects. The analysis cohort was 69.8% men, ages 53.6±8.9 years (mean±SD), body mass index of 32.3±4.5kg/m(2), with mild to severe OSA. At treatment initiation, subjects received random assignment to one night with and one without (control) treatment, and they were assessed again following 28 nights of treatment. Breathing and sleep architecture were assessed each night based on blind scoring by a single centralized scorer using AASM criteria.Average nightly usage across the take-home period was 6.0±1.4h. There were no severe or serious device-related adverse events (AEs). Median apnea-hypopnea index (AHI) was 27.5 events per hour on the control night, 13.4 events per hour on the first treatment night, and 14.8 events per hour after 28days of treatment. A clinically significant response (treatment AHI ?10/h and ?50% of control values) was seen in 20 of the 63 subjects evaluated. Rapid eye movement percentage (REM%) was significantly increased, and N1%, stage shifts to N1 sleep, overall stage shifts, total awakenings, and arousals per hour were all significantly reduced at both treatment nights compared to controls. Mean Epworth sleepiness scale (ESS) was significantly reduced from 12.1 to 8.6 (Cohen d effect size, 0.68) in those untreated for two or more weeks prior to OPT study participation and remained unchanged in subjects who directly switched from continuous positive airway pressure (CPAP) therapy to OPT.Clinically significant improvements in sleep quality and continuity, AHI, ODI, ESS, and overall clinical status were achieved in an easily identified subgroup. OPT was safe and well-tolerated and nightly usage was high.

Dataset Information

Efficacy of Oral Appliance Therapy as a First-Line Treatment for Moderate or Severe Obstructive Sleep Apnea: A Korean Prospective Multicenter Observational Study.

Publications

Efficacy of Oral Appliance Therapy as a First-Line Treatment for Moderate or Severe Obstructive Sleep Apnea: A Korean Prospective Multicenter Observational Study.

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