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Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: A randomized, placebo-controlled trial on temporomandibular side-effects.

ABSTRACT: PURPOSE:To assess the differences in the frequency of clinical signs of temporomandibular disorder (TMD) pain and mandibular function impairment between mandibular advancement device (MAD) and nasal continuous positive airway pressure (nCPAP) therapies in obstructive sleep apnea (OSA) patients at baseline and after 6 month of treatment. METHODS:This study concerns a secondary analysis of a randomized placebo-controlled trial in which different treatment effects of an objectively titrated MAD were compared with those of nCPAP and an intra-oral placebo appliance in a parallel design. Sixty-four mild to severe OSA patients (52.0?±?9.6?years) were randomly assigned to these three groups. All patients underwent a shortened functional examination of their masticatory system at baseline and after 6 months to establish the presence of clinical signs of TMD pain. Mandibular function impairment was assessed with a questionnaire. RESULTS:Clinical signs of TMD pain were only rarely present at baseline and therapy evaluation. No significant differences were found between the three groups in the (low) frequency of clinical signs of TMD pain at both time points (p = .401-.176). In addition, the (low) scores of mandibular function impairment did not differ between the three groups either, neither at baseline (p = .744) nor after 6 months (p = .359). CONCLUSIONS:A low frequency of clinical signs of TMD pain in mild to severe OSA patients was found after 6 months, regardless of treatment with MAD or nCPAP. In addition, no difference in mandibular function impairment was observed between the different treatment modalities.

SUBMITTER: Nikolopoulou M

PROVIDER: S-EPMC7453778 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: A randomized, placebo-controlled trial on temporomandibular side-effects.

Nikolopoulou Maria M Aarab Ghizlane G Ahlberg Jari J Hamburger Hans L HL de Lange Jan J Lobbezoo Frank F

Clinical and experimental dental research 20200404 4

<h4>Purpose</h4>To assess the differences in the frequency of clinical signs of temporomandibular disorder (TMD) pain and mandibular function impairment between mandibular advancement device (MAD) and nasal continuous positive airway pressure (nCPAP) therapies in obstructive sleep apnea (OSA) patients at baseline and after 6 month of treatment.<h4>Methods</h4>This study concerns a secondary analysis of a randomized placebo-controlled trial in which different treatment effects of an objectively t ...[more]

PMID: 32246748

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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:Background Studies have shown that a significant percentage of patients with obstructive sleep apnea (OSA) do not tolerate continuous positive airway pressure (CPAP) therapy and long-term use may be as low as 30%. Given the lower levels of symptoms and health-related risks, patients with mild sleep apnea may be at even higher risk for non-adherence to long term CPAP. The purpose of our study was to investigate the prevalence and associations of long-term CPAP adherence in first time users with mild sleep apnea diagnosed by home sleep apnea testing (HSAT). Methods We identified all the patients who were diagnosed with mild sleep apnea (5 = < AHI < 15) by home sleep apnea testing from 01/2013 to 06/2019 at a large, combined community and hospital-based sleep practice. Only first time CPAP users were included. Compliance was defined as CPAP usage ≥ 4 h per night on ≥ 70% of nights over 30 consecutive days. We defined long term adherence as compliance on the 12th month following CPAP set up. Patient demographics, comorbidities, and CPAP compliance at 1st, 3rd, 6th, 9th and 12th month after therapy initiation were collected. We compared and identified the factors that had significant difference (P < 0.1) between compliant and non-compliant groups at the 12th month. Results 222 patients were included in the analysis. 57 (25.7%) patients were adherent with long term CPAP treatment. The following factors were associated with a greater likelihood for long-term CPAP adherence: older age, lower body mass index (BMI), presence of a bed partner, non-smoker, presence of Diabetes Mellitus (DM), presence of Heart Failure (CHF), lack of depression, and compliance at 1st, 3rd, 6th and 9th month. Conclusions Long term CPAP compliance in mild sleep apnea patients is low. Long term adherence to CPAP can be predicted based on CPAP adherence during the first three months. Supplementary Information The online version contains supplementary material available at 10.1186/s12890-023-02612-3.

Dataset Information

Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: A randomized, placebo-controlled trial on temporomandibular side-effects.

Publications

Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: A randomized, placebo-controlled trial on temporomandibular side-effects.

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