Dataset Information

The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment.

ABSTRACT:

Study objectives

To evaluate and compare the effects of continuous positive airway pressure (CPAP), use of a mandibular advancement device (MAD), and no treatment on 24-hour ambulatory blood pressure monitoring and peripheral arterial tonometry at 6 and 12 months follow-up in individuals with mild obstructive sleep apnea (OSA), and in a subgroup who had an apnea-hypopnea index of < 5 events/h and adherence of ≥ 4 hours per night (effective-treatment subgroups).

Methods

The inclusion criteria were individuals with mild obstructive sleep apnea, any sex, age between 18 and 65 years, and a body mass index of ≤ 35 kg/m². Patients were randomized into CPAP, MAD, and no-treatment groups. The evaluations included physical examination, full polysomnography, 24-hour ambulatory blood pressure monitoring, and peripheral arterial tonometry at baseline and after 6 and 12 months. A generalized linear mixed model was used for comparisons.

Results

The CPAP and MAD groups had lower apnea-hypopnea indexes than the control group at 6 and 12 months, and the CPAP group had higher blood oxygen levels (SpO₂) than the MAD group. The MAD group had more hours of treatment per night and better adaptation to treatment than the CPAP group (MAD: 5.7 ± 2.7 h/night; CPAP: 3.8 ± 3.4 h/night; MAD: 16% did not adapt; CPAP: 42% did not adapt). No differences were found in the total sample and effective treatment in relation to peripheral arterial tonometry or 24-hour ambulatory blood pressure monitoring outcomes.

Conclusions

Treatment of mild obstructive sleep apnea with CPAP or MAD did not improve blood pressure or endothelial function after 1 year, even in patients with effective treatment.

Clinical trial registration

Registry: ClinicalTrials.gov; Name: Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT01461486; Identifier: NCT01461486.

SUBMITTER: Guimaraes TM

PROVIDER: S-EPMC7853217 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment.

Guimarães Thais Moura TM Poyares Dalva D Oliveira E Silva Luciana L Luz Gabriela G Coelho Glaury G Dal Fabbro Cibele C Tufik Sergio S Bittencourt Lia L

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20210201 2

<h4>Study objectives</h4>To evaluate and compare the effects of continuous positive airway pressure (CPAP), use of a mandibular advancement device (MAD), and no treatment on 24-hour ambulatory blood pressure monitoring and peripheral arterial tonometry at 6 and 12 months follow-up in individuals with mild obstructive sleep apnea (OSA), and in a subgroup who had an apnea-hypopnea index of < 5 events/h and adherence of ≥ 4 hours per night (effective-treatment subgroups).<h4>Methods</h4>The inclusi ...[more]

PMID: 32964829

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Project description:IntroductionAlthough treatment of obstructive sleep apnoea (OSA) using continuous positive airway pressure (CPAP) reduces blood pressure (BP), adherence to CPAP is often suboptimal. A mandibular advancement device (MAD) is a guideline-endorsed alternative therapy for OSA. Still, there is limited evidence on the relative efficacy between MAD and CPAP on BP reduction. We evaluate whether treatment of moderate-to-severe OSA using MAD can improve BP and other health-related outcomes compared with CPAP.Methods and analysisThis is a randomised, controlled, non-inferiority trial conducted. We will recruit 220 Asians with a history of hypertension and high cardiovascular risk for an overnight polysomnography screening. Those with moderate-to-severe OSA (apnoea-hypopnoea index ≥15 events/hour) will be randomised to treatment with either MAD or CPAP in a 1:1 ratio. Stratified by age (60 vs <60 years old), body mass index (25 vs <25 kg/m2) and apnoea-hypopnoea index (30 vs <30 events/hour), an adaptive randomisation scheme with permuted blocks constructed in real-time is implemented to restrict imbalance. The overall study duration is 12 months. The primary endpoint is the 24-hour mean arterial BP difference between baseline and 6-month follow-up. The secondary endpoints include other measures of ambulatory BP monitoring, arrhythmia based on a 4-day electrocardiographic monitoring, biomarker and proteomic analysis, cardiovascular magnetic resonance-derived myocardial fibrosis and remodelling and quality-of-life questionnaires. Recruitment began in October 2019 and ended in December 2022. Comparison between MAD and CPAP will be performed using covariance (ANCOVA) analysis of the changes in 24-hour mean arterial BP while adjusting for the baseline 24-hour mean arterial BP. We will compare the 95% CIs around the treatment difference point estimate with the prespecified non-inferiority margin (1.5 mm Hg). If the upper limit of the 95% CI is <1.5 mm Hg and crosses 0, non-inferiority of the MAD relative to CPAP will be established.Ethics and disseminationThe Domain Specific Review Board-C, National Healthcare Group under approved the study protocol (NHG DSRB Ref: 2019/00359, approved on 28 August 2019). Study findings will be disseminated to various local, national, and international audiences through abstract presentations and publication in peer-reviewed journals.Trial registration numberNCT04119999.

Project description:Study objectivesObstructive sleep apnea (OSA) is associated with cardiovascular comorbidities such as left ventricular (LV) hypertrophy. Whether OSA is an independent etiological factor for this hypertrophic remodeling is yet unknown. Continuous positive airway pressure partially reverses this hypertrophy, but data regarding the effect of mandibular advancement devices on LV remodeling are scarce. The aim of this prospective trial is to evaluate the effect of mandibular advancement device therapy on LV geometry and function in patients with OSA.MethodsAt baseline and 6-month follow-up, participants underwent a home sleep apnea test, 24-hour ambulatory blood pressure monitoring and a 2-dimensional Doppler and tissue Doppler echocardiography.ResultsSixty-three patients (age: 49 ± 11 years; body mass index: 27.0 ± 3.4 kg/m2; baseline apnea-hypopnea index home sleep apnea test: 11.7 [8.2; 24.9] events/h) completed the 6-month follow-up visit. Overall, blood pressure values and parameters of LV function were within normal ranges at baseline and did not change under mandibular advancement device therapy. In contrast, the interventricular septum thickness was at the upper limits of normal at baseline and showed a significant decrease at 6-month follow-up (11.1 ± 2.1 mm vs 10.6 ± 2.0 mm, P = .03). This significant improvement is only found in responders but not in nonresponders. There was no correlation between the decrease of interventricular septum thickness and the change in blood pressure.ConclusionsIn mildly obese, normotensive patients with OSA we observed significant reverse hypertrophic remodeling after 6 months of successful mandibular advancement device therapy, with maintained normotensive systemic blood pressure. This suggests that OSA is an independent factor in the pathophysiology of LV hypertrophy in these patients.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT02320877; Identifier: NCT02320877.CitationDieltjens M, Vanderveken OM, Shivalkar B, et al. Mandibular advancement device treatment and reverse left ventricular hypertrophic remodeling in patients with obstructive sleep apnea. J Clin Sleep Med. 2022;18(3):903-909.

Project description:BackgroundThe efficacy of mandibular advancement devices (MAD) and maxillomandibular advancement (MMA) in improving upper airway (UA) patency has been described as being comparable to continuous positive airway pressure (CPAP) outcomes. However, no previous study has compared MAD and MMA treatment outcomes for the upper airway enlargement. This study aimed to evaluate three-dimensionally the UA changes and mandibular rotation in patients after MAD compared to MMA.MethodsThe sample consisted of 17 patients with treated with MAD and 17 patients treated with MMA matched by weight, height, body mass index. Cone-beam computed tomography from before and after both treatments were used to measure total UA, superior/inferior oropharynx volume and surface area; and mandibular rotation.ResultsBoth groups showed a significant increase in the superior oropharynx volume after the treatments (p = 0.003) and the MMA group showed greater increase (p = 0.010). No statistical difference was identified in the MAD group considering the inferior volume, while the MMA group showed a significantly gain (p = 0.010) and greater volume (p = 0.024). Both groups showed anterior mandibular displacement. However, the mandibular rotation were statistically different between the groups (p < 0.001). While the MAD group showed a clockwise rotation pattern (-3.97 ± 1.07 and - 4.08 ± 1.30), the MMA group demonstrated a counterclockwise (2.40 ± 3.43 and 3.41 ± 2.79). In the MAD group, the mandibular linear anterior displacement was correlated with superior [p = 0.002 (r=-0.697)] and inferior [p = 0.004 (r = 0.658)] oropharynx volume, suggesting that greater amounts of mandibular advancement are correlated to a decrease in the superior oropharynx and an increase in the inferior oropharynx. In the MMA group, the superior oropharynx volume was correlated to mandibular anteroposterior [p = 0.029 (r=-0.530)] and vertical displacement [p = 0.047 (r = 0.488)], indicating greater amounts of mandibular advancement may lead to a lowest gain in the superior oropharynx volume, while a great mandibular superior displacement is correlated with improvements in this region.ConclusionsThe MAD therapy led to a clockwise mandibular rotation, increasing the dimensions of the superior oropharynx; while a counterclockwise rotation with greater increases in all UA regions were showed in the MMA treatment.

Project description:Study objectivesObstructive sleep apnea (OSA) is a sleep-related breathing disorder, commonly managed by either continuous positive airway pressure (CPAP) or a mandibular advancement device (MAD). Long-term follow-up and comparison regarding efficacy of these therapies is scarce. In this study the results of treatment, patient adherence, and satisfaction over a 10-year follow-up of these therapies are reported.MethodsThis is a longitudinal follow-up study taken from a subset of patients initially enrolled in a randomized controlled clinical trial of 103 patients with OSA (51 and 52 patients randomized for MAD and CPAP, respectively). After a 10-year follow-up period, 14 patients using MAD and 17 patients using CPAP could be evaluated for this longitudinal follow-up study. Data were analyzed at baseline, after 3 months and at 1-, 2-, and 10-year follow-up. All 31 patients with OSA underwent polysomnography and self-reported measurements.ResultsPolysomnography results showed a favorable outcome of both therapies at 10-year follow-up. At baseline, included patients in both groups did not significantly differ in apnea-hypopnea index (AHI) values. At 10-year follow-up, both the MAD and CPAP groups showed a significant reduction in AHI. At baseline the mean AHI in the MAD group was 31.7 ± 20.6 events/h whereas in the CPAP group it was 49.2 ± 26.1 events/h. At 10-year follow-up the mean AHI in the MAD group was 9.9 ± 10.3 events/h and in the CPAP group it was 3.4 ± 5.4 events/h. Both therapies resulted in a substantial improvement in self-reported neurobehavioral outcomes at 10-year follow-up.ConclusionsBoth CPAP and MAD therapy demonstrate good and stable treatment effects after a 10-year follow-up period. Therefore, when indicated, both therapies are appropriate modalities for the long-term management of OSA.Clinical trial registrationRegistry: Netherlands Trial Register; Name: Management of the Obstructive Sleep Apnea-Hypopnea Syndrome: Oral Appliance versus Continuous Positive Airway Pressure Therapy; Identifier: NL75; URL: https://www.trialregister.nl/trial/75.

Dataset Information

The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment.

Study objectives

Methods

Results

Conclusions

Clinical trial registration

Publications

The treatment of mild OSA with CPAP or mandibular advancement device and the effect on blood pressure and endothelial function after one year of treatment.

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