Ready-Made Versus Custom-Made Mandibular Repositioning Devices in Sleep Apnea: A Randomized Clinical Trial.
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SUBMITTER: Johal A
PROVIDER: S-EPMC5263072 | biostudies-other | 2017 Feb
REPOSITORIES: biostudies-other
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Project description:Study objectivesTo compare the effects of mandibular advancement device (MAD) therapy on upper airway dimensions between responders and non-responders with mild to moderate obstructive sleep apnea (OSA).MethodsThirty-one participants (21 men and 10 women) with a mean ± SD apnea-hypopnea index (AHI) of 16.6 ± 6.7 events/h, and aged 48.5 ± 13.9 years, were included in this study. Polysomnographic recordings and cone beam computed tomography (CBCT) scans in supine position were performed for every participant at baseline and at 3-month follow-up with their MAD in situ. Responders were defined as having ≥ 50% reduction in baseline AHI with a residual AHI < 10 events/h. The primary outcome variable was the minimal cross-sectional area of the upper airway (CSAmin).ResultsNo significant differences were found between responders (n = 15) and non-responders (n = 16) in age, gender distribution, body mass index, and neck circumference (P = 0.06-0.93), nor in AHI and CSAmin (P = 0.40 and 0.65, respectively) at baseline. The changes of the CSAmin with MAD in situ in the responder group were not significantly different compared to those in the non-responder group (P = 0.06).ConclusionWithin the limitations of this study, we conclude that the changes of the upper airway dimensions induced by MADs are not significantly different between responders and non-responders with mild to moderate OSA.Trial registrationClinicalTrials.gov Identifier: NCT02724865. https://clinicaltrials.gov/ct2/show/NCT02724865.
| S-EPMC10492877 | 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
Project description:Obstructive sleep apnea (OSA) is a common but still underrecognized disorder. A mandibular repositioning appliance (MRA) is used to treat OSA by advancing the mandible and thereby reducing the collapsibility of the upper airway. It has been found that an MRA increases the volume of the upper airway, especially the velopharyngeal area, in OSA patients. We hypothesize that this increase in the velopharyngeal volume is associated with an anterior displacement of the tongue, but likely not with a stretching of the soft tissue connecting the soft palate, lateral pharynx, palatopharyngeal arch, and mandible. Since the function and structure of the genioglossus and hypoglossal nerve are always abnormal in patients with OSA, the tongue does not always move simultaneously with the mandible when an MRA is being used. Oropharyngeal exercises, especially tongue exercises, can improve the quality of life of OSA patients, including reduction of daytime sleepiness and snoring, better quality of sleep, and partial decrease in the AHI. Further, in animal models, tongue exercise is also found to be effective in tongue function recovery and in the remodeling of the hypoglossal nucleus. We suggest that a combination of tongue exercises along with MRA is a promising approach for patients who do not respond to an MRA alone.
| S-EPMC6247694 | 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:Importance:Uncorrected refractive errors are the most common cause of visual impairment in children despite correction being highly cost-effective. Objective:To determine whether less expensive ready-made spectacles produce rates of spectacle wear at 3 to 4 months comparable to those of more expensive custom-made spectacles among eligible school-aged children. Design, Setting, and Participants:This noninferiority, double-masked, randomized clinical trial recruited children aged 11 to 15 years from January 12 through July 31, 2015, from government schools in urban and periurban areas surrounding Bangalore, India. Follow-up occurred from August 1 through September 31, 2015. Participants met the following eligibility criteria for ready-made spectacles: failed vision screening at the 6/9 level in each eye; refraction was indicated; acuity improved with correction by 2 or more lines in the better-seeing eye; the corrected acuity with the spherical equivalent was not more than 1 line less than with full correction; anisometropia measured less than 1.0 diopter; and an appropriate frame was available. Interventions:Eligible children were randomized to ready-made or custom-made spectacles. Main Outcomes and Measures:Proportion of children wearing their spectacles at unannounced visits 3 to 4 months after the intervention. Results:Of 23?345 children aged 11 to 15 years who underwent screening, 694 had visual acuity of less than 6/9 in both eyes, and 535 underwent assessment for eligibility. A total of 460 children (227 female [49.3%] and 233 male [50.7%]; mean [SD] age, 13.4 [1.3] years) were eligible for ready-made spectacles (2.0% undergoing screening and 86.0% undergoing assessment) and were randomized to ready-made (n?=?232) or custom-made (n?=?228) spectacles. Follow-up rates at 3 to 4 months were similar (184 [79.3%] in the ready-made group and 178 [78.1%] in the custom-made group). Rates of spectacle wear in the 2 arms were similar among 139 of 184 children (75.5%) in the ready-made arm and 131 of 178 children (73.6%) in the custom-made arm (risk difference, 1.8%; 95% CI, -7.1% to 10.8%). Conclusions and Relevance:Most children were eligible for ready-made spectacles, and the proportion wearing ready-made spectacles was not inferior to the proportion wearing custom-made spectacles at 3 to 4 months. These findings suggest that ready-made spectacles could substantially reduce costs for school-based eye health programs in India without compromising spectacle wear, at least in the short term. Trial Registration:isrctn.com Identifier: ISRCTN14715120.
| S-EPMC5847082 | biostudies-literature
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.
| S-EPMC8883079 | biostudies-literature
Project description:Objective:Ready-made spectacles have been suggested as a less resource-intensive treatment for the millions of people living with uncorrected refractive error (URE) in low-income environments. In spite of this interest, there have been no published economic evaluations examining the cost-effectiveness of ready-made spectacles. This study aims to determine the relative cost-effectiveness of offering ready-made spectacles (RMS) relative to no intervention as well as the relative cost-effectiveness of custom-made spectacles (CS) relative to RMS to treat URE. Methods and analysis:The relative cost-effectiveness of RMS relative to CS and no intervention was tested through a cost-effectiveness analysis from the health service provider perspective conducted alongside a double-masked randomised controlled trial in an urban hospital in Delhi, India. Participants were adults aged 18-45 years with ?1?dioptre (D) of URE. Results:There was no significant difference between the effectiveness of the CS and RMS interventions in improving visual acuity, but the CS was over four times the price of the RMS per patient (204 INR (US$2.42) and 792 INR (US$11.22)). The cost per unit improvement in logarithm of the minimum angle of resolution (logMAR) relative to baseline with the RMS intervention was 407 INR (US$4.35). Existing estimates of utility resulting from improvements in visual acuity result in incremental cost per quality-adjusted life years gained of between 212 INR and 1137 INR (US$0.44-US$23.74) depending on the source of the utility estimate and assumed expected life of the spectacles. Conclusion:RMS represent a significantly cost-effective option for spectacle provision in low-resource settings. The RMS programme was substantially cheaper than an equivalent CS intervention while being effective in improving visual acuity for the majority of adults with refractive error in this setting. These findings provide further support for including RMS in programmes to address URE. Trial registration number:NCT00657670, Results.
| S-EPMC5895972 | biostudies-literature
Project description:We sought to evaluate visual performance and satisfaction with ready-made spectacles (RMS) in Chinese school-aged children with uncorrected refractive error.Randomized, double-blind, clinical trial.Junior high school students from urban Guangzhou, China, aged approximately 12 to 15 years with > or =1 diopter (D) of uncorrected spherical equivalent (SE) refractive error. Students were excluded with > or =2.00 D astigmatism, > or =2 D myopic anisometropia, and > or =1 D hyperopic anisometropia and ocular disease affecting vision.Refractive error was determined by cycloplegic subjective refraction. Students were randomly assigned to receive RMS or custom spectacles (CS) and assessed after 1 month of use. We required 175 students to complete in each arm to be able to measure a 15% difference in compliance.Compliance with spectacles lens wear, patterns of use, vision, symptoms, and perceived value.Screening identified 965 of 4607 (20.9%) students with reduced distance vision; 212 of the 965 (22.0%) refused evaluation and 187 of the 965 (20.8%) had <1 D of SE refractive error. Sixty-one (6.3%) were referred for further evaluation and the remaining 495 (51.3%) participated. Social, demographic, and ocular parameters were similar in the 2 groups. Average SE refractive error was -2.57+/-1.31 (mean value +/- standard deviation [SD]). Spectacle vision (Snellen acuity, mean +/- SD) was worse with RMS in the eye with lower SE (20/25(-0.5)+/-0.9 lines vs 20/25(+1)+/-0.7 lines; P = 0.004) and higher SE (20/25(-2)+/-1.2 lines vs 20/25(+1)+/-0.8; P<0.001). There were no differences (P>0.05) in the rate of use (94.3% vs 92.2%), wearing to the 1-month visit (46.9% vs 51.5%), planned use (93.3% vs 93.7%), value (89.5% vs 91.7% "moderate or high value or most valued possession"), or symptoms (blur, 21.1% vs 19.4% [P = 0.8] and other symptoms [P>0.2]).Although visual acuity was better with CS, no difference was found in acceptability in this population of students with predominantly simple myopic refractive error. This study supports the use of RMS in a school-based refractive services program, saving costs and improving the logistics of service delivery.
| S-EPMC4252048 | biostudies-literature
Project description:Study objectivesObstructive sleep apnea-hypopnea (OAH) diagnosis in children is based on the quantification of flow and respiratory effort (RE). Pulse transit time (PTT) is one validated tool to recognize RE. Pattern analysis of mandibular movements (MM) might be an alternative method to detect RE. We compared several patterns of MM to concomittant changes in PTT during OAH in children with adenotonsillar hypertrophy.MethodsParticipants33 consecutive children with snoring and symptoms/signs of OAH.MeasurementsMMs were measured during polysomnography with a magnetometer device (Brizzy Nomics, Liege, Belgium) placed on the chin and forehead. Patterns of MM were evaluated representing peak to peak fluctuations > 0.3 mm in mandibular excursion (MML), mandibular opening (MMO), and sharp MM (MMS), which closed the mouth on cortical arousal (CAr).ResultsThe median (95% CI) hourly rate of at least 1 MM (MML, or MMO, or MMS) was 18.1 (13.2-36.3) and strongly correlated with OAHI (p = 0.003) but not with central apnea-hypopnea index (CAHI; p = 0.292). The durations when the MM amplitude was > 0.4 mm and PTT > 15 ms were strongly correlated (p < 0.001). The mean (SD) of MM peak to peak amplitude was larger during OAH than CAH (0.9 ± 0.7 mm and 0.2 ± 0.3 mm; p < 0.001, respectively). MMS at the termination of OAH had larger amplitude compared to MMS with CAH (1.5 ± 0.9 mm and 0.5 ± 0.7 mm, respectively, p < 0.001).ConclusionsMM > 0.4 mm occurred frequently during periods of OAH and were frequently terminated by MMS corresponding to mouth closure on CAr. The MM findings strongly correlated with changes in PTT. MM analysis could be a simple and accurate promising tool for RE characterization and optimization of OAH diagnosis in children.
| S-EPMC4410931 | 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