Long term therapeutic efficacy of a soft monobloc mandibular advancement device in adults with obstructive sleep apnea.
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ABSTRACT:
SUBMITTER: Ballanti F
PROVIDER: S-EPMC4302378 | biostudies-other | 2015
REPOSITORIES: biostudies-other
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Project description:There is increasing evidence that mandibular advancement devices (MADs) can be an effective treatment for some patients with obstructive sleep apnea, a highly prevalent chronic disease. In this study, the objectives were to objectively assess the effectiveness of MAD therapy using a limited channel recorder, and to develop a model for identifying patients who may be appropriate for MAD therapy as the initial treatment option. Thirty patients were prospectively recruited and studied at two independent dentist offices and the participants' homes. Subjects wore the ARES Unicorder for two nights before insertion of the MAD, and again when the dentist determined that the patient had reached the titration endpoint. Self-reported measures of depression, sleepiness, and quality of life were obtained pre- and posttreatment. The reviewer was blinded to the study status while the physiological signals were being visually inspected. Significant reductions in the apnea/hypopnea index (AHI), hypoxemia measures, and snoring level were observed posttreatment. Twenty-seven of the 30 (90%) patients had a posttreatment AHI (using a 4% desaturation for hypopneas) below a clinical cut-off of 10. All but one patient (97%) exhibited at least a 50% decrease in AHI or had a posttreatment AHI < or = 10. Significant differences in body mass index, weight, and neck circumference in patients with posttreatment AHIs above and below a clinical cut-off of five were identified. The linear regression used to predict the posttreatment AHI using pretreatment data resulted in an R(2) of 0.68. The model correctly predicted two patients who were unable to obtain a posttreatment AHI of 10 or less. This study was designed to demonstrate two models of collaboration between a dental sleep medicine specialist and a sleep medicine physician in the monitoring of a patient treated with a MAD. The outcome data suggest that the limited channel recording system can be used as an alternative to laboratory polysomnography to reduce the cost of MAD treatment, and to improve the quality and consistency of posttreatment patient care.
| S-EPMC2270921 | biostudies-other
Project description:Interrelationships between obstructive sleep apnea (OSA) and cardiovascular diseases are now recognized, but some underlying pathophysiological mechanisms remain controversial. Circulating cardiac biomarkers are diagnostic tools that can help understand them, in particular the N-terminal pro-brain natriuretic peptide (NT-proBNP), a marker of myocardial stretch, and a potential indicator of subclinical cardiac stress in OSA. Continuous positive airway pressure (CPAP), the first-line treatment of moderate to severe OSA, may be considered as uncomfortable, resulting in poor adherence, and reduced effectiveness. In this case, mandibular advancement devices (MAD) are an effective alternative therapy, more comfortable, and generally well accepted, with higher compliance. To date, few studies have compared the cardiovascular effects of CPAP and MAD. From recent literature reviews, it emerges that both therapies are effective in blood pressure reduction. However, the effects of MAD on other cardiovascular outcomes are conflicting, in particular as regards to its impact on circulating cardiac biomarkers. In a recent ancillary study from a randomized controlled trial, Recoquillon et al concluded that two months of MAD treatment had no effect on NT-proBNP plasma levels in patients with severe OSA. The present discussion analyses this result from a biological, statistical, and analytical standpoint, in light of results from other studies evaluating natriuretic peptides in MAD-treated OSA, with the aim to support further longitudinal studies designed with a high methodological quality.
| S-EPMC6415324 | biostudies-literature
Project description:STUDY OBJECTIVES:Limited evidence exists on the cost-effectiveness of mandibular advancement device (MAD) compared to continuous positive airway pressure (CPAP) therapy in moderate obstructive sleep apnea (OSA). Therefore, this study compares the clinical and cost-effectiveness of MAD therapy with CPAP therapy in moderate OSA. METHODS:In a multicentre randomized controlled trial, patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h were randomized to either MAD or CPAP. Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR, in terms of AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire]) were calculated after 12 months, all from a societal perspective. RESULTS:In the 85 randomized patients (n = 42 CPAP, n = 43 MAD), AHI reduction was significantly greater with CPAP (median reduction AHI 18.3 [14.8-22.6] events/h) than with MAD therapy (median reduction AHI 13.5 [8.5-18.4] events/h) after 12 months. Societal costs after 12 months were higher for MAD than for CPAP (mean difference €2.156). MAD was less cost-effective than CPAP after 12 months (ICER -€305 [-€3.003 to €1.572] per AHI point improvement). However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained). CONCLUSIONS:CPAP was more clinically effective (in terms of AHI reduction) and cost-effective than MAD. However, costs per QALY was better with MAD as compared to CPAP. Therefore, CPAP is the first-choice treatment option in moderate OSA and MAD may be a good alternative. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov; Identifier: NCT01588275.
| S-EPMC6778341 | biostudies-literature
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.
| S-EPMC7075089 | biostudies-literature
Project description:Study objectivesComparable health effects of mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy have been attributed to higher adherence with MAD compared with CPAP therapy. The objective of this study was to make a direct comparison of the objective adherence between MAD and CPAP in patients with moderate obstructive sleep apnea (OSA).MethodsAdherence was monitored for 12 months in 59 patients with moderate OSA (apnea-hypopnea index 15-30 events/h) as part of a randomized controlled trial. Objective adherence with MAD was assessed using the TheraMon microsensor. Objective adherence with CPAP was assessed using the built-in registration software with readout on SD card. Self-reported adherence with both therapies was assessed using a questionnaire.ResultsForty patients (68%) completed the study with the therapy to which they were randomly assigned. Median (interquartile range) objective adherence (h/night) in the 3rd month was 7.4 (5.2-8.2) for MAD and 6.8 (5.7-7.6) for CPAP (P = .41), compared to 6.9 (3.5-7.9) with MAD and 6.8 (5.2-7.6) with CPAP (P = .85) in the 12th month. There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46). Changes in adherence were not significantly different between MAD and CPAP (P = .51). Self-reported adherence was significantly higher with MAD than CPAP at all follow-ups. Self-reported adherence with CPAP was lower than objective CPAP adherence at the 6th and 12th month (P = .02).ConclusionsObjective adherence with MAD and CPAP is comparable and consistent over time. Self-reported adherence is higher with MAD than with CPAP giving rise to interesting discrepancy between objective and self-reported adherence with CPAP.Clinical trial registrationRegistry: ClinicalTrials.gov; Identifier: NCT01588275.
| S-EPMC6853388 | biostudies-literature
Project description:Although considerable research highlights the interactions between obstructive sleep apnea-hypopnea syndrome (OSAHS) and cardiovascular diseases, the effect of mandibular advancement device (MAD) treatment on cardiovascular complications in OSAHS patients remains unclear. We evaluated the effect of OSAHS treatment with MADs on the myocardium. All methods in this study were in accordance with relevant guidelines and regulations of the medical ethics committee in Hospital of Stomatology, Hebei Medical University approved the work. Thirty New Zealand rabbits were randomized into three groups: the control group, Group OSAHS, and Group MAD. Hydrophilic polyacrylamide gel was injected into the soft palate of the rabbits to induce OSAHS. In Group MAD, a MAD was positioned after OSAHS induction. All animals were induced to sleep in a supine position for 4-6?h/day for 8 weeks. Echocardiography was used to determine the structure and function of the heart. The histological changes were detected by optical microscopy and transmission electron microscopy (TEM). The levels of ET-1(endothelin-1) and Ang II (Angiotensin II) in the plasma were measured by an enzyme-linked immunosorbent assay (ELISA). The expression of ET-1 mRNA in heart tissue was detected by RT-PCR. Histological abnormalities, left ventricular hypertrophy, and left ventricular dysfunctions were demonstrated in Group OSAHS, and the abnormities were rescued with MAD treatment. Higher levels of plasma ET-1 and Ang II and elevated expression of ET-1 mRNA in cardiac tissue were detected in Group OSAHS compared with Group MAD and the control group. The blood oxygen saturation was negatively correlated with the levels of ET-1 and Ang II. OSAHS-induced elevated levels of ET-1 and Ang II may be attributed to myocardial structural abnormalities and dysfunction. Early treatment of MADs may play an important role in preventing myocardial damage in OSAHS rabbit model.
| S-EPMC7042252 | biostudies-literature
Project description:The aim of this study was to investigate the effects of mandibular advancement device (MAD) therapy for obstructive sleep apnea-hypopnea syndrome (OSAHS) on hypoxia-inducible factor-1α (HIF-1α), erythropoietin (EPO) and vascular endothelial growth factor (VEGF) in myocardial tissue. New Zealand rabbits were used to develop OSAHS and MAD models. Cone beam computed tomography (CBCT) of the upper airway and polysomnography (PSG) recordings were performed with the animals in the supine position. All of the animals were induced to sleep in a supine position for 4-6 h each day and were observed continuously for 8 weeks. The myocardial tissue of the three groups was dissected to measure the expression of HIF-1α, EPO and VEGF. The results showed that there was higher expression of HIF-1α, EPO and VEGF in the OSAHS group than those in the MAD and control groups. MAD treatment significantly downregulated the expression of HIF-1α, EPO and VEGF in the OSAHS animals. We concluded that MAD treatment could significantly downregulate the increased expression of HIF-1α, EPO and VEGF in OSAHS rabbits, improving their myocardial function.
| S-EPMC7414037 | biostudies-literature
Project description:Obstructive sleep apnea syndrome (OSAS) is a major public health problem which affects between 5 to 10% of the general population. OSAS is known to be associated with high rates of morbidity and mortality mainly due to cardiovascular diseases and traffic accidents. The burden of illness is high for the individual and society. There are 2 treatment options for OSAS, Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Device therapy (MAD). CPAP is known to be an effective but very constraining treatment. Patients are usually poorly adherent. MAD is a more recent treatment easier to use and consequently better tolerated, but MAD can only be prescribed to patients with satisfactory oral hygiene. Oral health constitutes a real issue particularly among underprivileged groups in France. Through this link, the question of whether low socio-economic status constitutes a barrier to access to care for patients with OSAS is raised.In a multicenter prospective cohort of 2822 consecutive OSAS patients in whom MAD has been proposed as an alternative to CPAP between May 15, 2007 and December 1st, 2014, we identified the factors that lead to a patient diagnosed with OSAS to be treated by MAD instead of CPAP. A logistic regression was performed using a stepwise forward procedure. The main outcome of the study was that treatment by MAD was significantly associated with both educational attainment, as determined by the age at which the patient left full-time education, ≥18 years compared with <18 (adjusted odds ratio (aOR): 1.64, 95% CI 1.23 to 2.20), and the patient's occupational category. Executives and higher intellectual professions, intermediate professions, technicians, foremen and employees were significantly more likely to be treated by MAD than workers (aOR: 2.21, 95% CI 1.88 to 2.58; aOR: 1.74, 95% CI 1.15 to 2.63; aOR: 1.96, 95% CI 1.11 to 3.47, respectively).Overall, these results suggest that low socio-economic status constitutes a barrier to access to MAD for patients with OSAS in France. MAD use in patients with OSAS highlights inequalities in health care access.
| S-EPMC4581831 | biostudies-other
Project description:PURPOSE:To find out if a moderate protrusion with a mandibular advancement device (MAD) can significantly increase the upper airway volume and, further, what signs and symptoms of obstructive sleep apnea (OSA) can be improved by this maneuver. METHODS:There were 58 adults diagnosed with OSA who were referred for MAD therapy. The mean apnea-hypopnea index (AHI) was 19.2 (SD 8.6). Five indicators of signs and symptoms of OSA (AHI, oxygen saturation, snoring, daytime sleepiness, and health-related quality of life) were evaluated at the baseline and after 6 months of MAD therapy. Nasal resistance and airway volume and cross-sectional areas with and without the MAD in situ were recorded. Based on AHI reduction, the treatment response was classified as complete, partial, or non-complete. Statistical analyses included the chi-square, t tests, Mann-Whitney U tests, and regression analyses (linear and logistic). RESULTS:Twenty-three patients attained a complete response (residual AHI < 5 events/h) to MAD therapy. In 13 subjects, the response was partial, and in 9 patients, it was non-complete. The complete responders were significantly younger, and they had a deeper overbite than partial/non-complete responders. A convex profile associated positively, but a vertically restricted throat and increased lower facial height associated negatively with the increase in airway volume. CONCLUSIONS:Excellent MAD therapy outcomes were achieved in most patients. Only age and deep bite had some influence on AHI reduction, indicating multifactorial nature in the response to MAD therapy.
| S-EPMC7426308 | biostudies-literature
Project description:PURPOSE:Mandibular repositioning devices (MRDs) are an effective treatment option for obstructive sleep apnea syndrome (OSAS), particularly in patients who refuse or cannot tolerate continuous positive airway pressure (CPAP). However, sex differences in the response to therapy and predictors of response are not clearly defined. This analysis of data from the long-term prospective ORCADES trial compared MRD efficacy in men and women with OSAS. METHODS:The ORCADES study included patients with newly diagnosed mild-to-moderate or severe OSAS who refused or were non-compliant with CPAP. MRD therapy was titrated over 3-6 months. The primary endpoint was treatment success (??50% decrease in apnea-hypopnea index (AHI)). Complete response was defined using a range of AHI cut-off values (<?5/h, <?10/h, <?15/h). RESULTS:Overall treatment success rates were 89% in women and 76% in men (p =?0.019); corresponding rates in those with severe OSAS (AHI >?30/h) were 100% and 68% (p =?0.0015). In women vs. men, overall complete response rates at AHI cut-off values of <?5/h, <10/h, and <?15/h were 49 vs. 34% (p =?0.0052), 78 vs. 62% (p =?0.016), and 92 vs. 76% (p =?0.0032). On multivariate analysis, significant predictors of MRD treatment success were overbite and baseline apnea index in men, and neck circumference and no previous CPAP therapy in women. There were sex differences in the occurrence of side effects. Temporomandibular joint pain was the most common reason for stopping MRD therapy. CONCLUSIONS:MRD therapy was effective in women with OSA of any severity, with significantly higher response rates compared with men especially in severe OSAS. TRIAL REGISTRATION:www.clinicaltrials.gov (NCT01326143).
| S-EPMC6700234 | biostudies-literature