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Comparison of success criteria based on long-term symptoms and new-onset hypertension in mandibular advancement device treatment for obstructive sleep apnoea: observational cohort study.

ABSTRACT: OBJECTIVE:To identify adequate criteria to determine the success or failure of mandibular advancement device (MAD) treatment for obstructive sleep apnoea (OSA) based on long-term symptoms and new-onset hypertension. DESIGN:Observational cohort study. SETTING:A tertiary care hospital setting in South Korea. PARTICIPANTS:Patients (age >18 years) who were diagnosed with OSA by a polysomnography (PSG) or Watch peripheral arterial tonometry (PAT), and who had been treated with MAD between January 2007 and December 2014 were enrolled. PRIMARY AND SECONDARY OUTCOME MEASURES:Patients underwent PSG or Watch PAT twice; before and 3 months after the application of MAD. The patients were categorised into success and failure groups using seven different criteria. MAD compliance, witnessed apnoea and snoring, Epworth Sleepiness Scale score and occurrence of new-onset hypertension were surveyed via telephonic interview to determine the criteria that could identify success and failure of MAD. RESULTS:A total of 97 patients were included. The mean follow-up duration was 60.5 months, and the mean apnoea-hypopnoea index (AHI) was 35.5/hour. Two of the seven criteria could significantly differentiate the success and failure groups based on long-term symptoms, including (1) AHI<10/hour with MAD and (2) AHI<10/hour and AHI reduction of >50% with MAD. Kaplan-Meier survival analysis showed that one criterion of AHI<15/hour with MAD could differentiate the success and failure groups based on new-onset hypertension (p=0.035). The receiver operating characteristic curve analysis indicated that the cut-off AHI for new-onset hypertension was 16.8/hour (71.4% sensitivity and 75.0% specificity). CONCLUSION:Our long-term follow-up survey for symptoms and new-onset hypertension suggested that some of the polysomnographic success criteria, that is, AHI<10/hour with MAD, AHI<10/hour and AHI reduction of >50% with MAD and AHI<15/hour with MAD may be useful in distinguishing the success group from failure one. Further prospective longitudinal studies are warranted to validate these criteria.

SUBMITTER: Wee JH

PROVIDER: S-EPMC5942426 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Comparison of success criteria based on long-term symptoms and new-onset hypertension in mandibular advancement device treatment for obstructive sleep apnoea: observational cohort study.

Wee Jee Hye JH Lim Jae Hyun JH Gelera January E JE Rhee Chae-Seo CS Kim Jeong-Whun JW

BMJ open 20180508 5

<h4>Objective</h4>To identify adequate criteria to determine the success or failure of mandibular advancement device (MAD) treatment for obstructive sleep apnoea (OSA) based on long-term symptoms and new-onset hypertension.<h4>Design</h4>Observational cohort study.<h4>Setting</h4>A tertiary care hospital setting in South Korea.<h4>Participants</h4>Patients (age >18 years) who were diagnosed with OSA by a polysomnography (PSG) or Watch peripheral arterial tonometry (PAT), and who had been treated ...[more]

PMID: 29739785

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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: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.

Project description:BackgroundObstructive sleep apnoea (OSA) is a sleep-related breathing disorder characterised by the repeated episodic collapse of the upper airway during sleep, resulting in sleep deprivation, giving rise to apnoeas and hypopnoeas. Based on the severity of OSA, there are two primary treatment modalities, continuous positive airway pressure (CPAP) and mandibular advancement appliances (MAA); both are adherence-dependent. MAA is offered to those with mild to moderate OSA and is prescribed as an alternative to patients intolerable to CPAP. However, adherence to MAA treatment is variable and declines over time. Hence, the current study aims to assess the effectiveness of the stage-matched intervention, the Health Action Process Approach (HAPA), on adherence to MAA in patients with OSA.MethodsA single-centre randomised clinical trial will be undertaken at Bart's Health NHS Trust. Fifty-six participants with newly diagnosed OSA are planned to be enrolled in the study and randomised to intervention care (IC) and standardised care (SC) groups. Participants in the SC group will receive routine care whilst participants in the IC group will receive the stage-matched intervention, developed using the HAPA model. Data indicating MAA adherence will be collected both objectively and subjectively, from micro-sensors embedded in the MAA design and sleep diaries, respectively at 3, 6, 18 and 36 months. In addition, a range of questionnaires designed to assess risk perception, outcome expectancy, and self-efficacy (SEMSA) and quality of sleep (PSQI and ESS) and life (EQ-5DL), socio-economic and social support scales will be used.DiscussionThe currently available treatments for obstructive sleep apnoea depend entirely on the patient's acceptance and use. There are several factors that affect cooperation and wear for example patients' awareness of their condition, social support and psychological behaviour. In addition, mood, such as anxiety, stress, and depression, may affect wear. At the same time, we know that interventions involving more education and behaviour approaches can help patients adapt more easily to some treatments. As a result, the present trial aims to explore the potential role of these factors to maximise treatment success and minimise side effects.Trial registrationClinicalTrials.gov NCT04092660 . Registered on September 6, 2019.

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

Comparison of success criteria based on long-term symptoms and new-onset hypertension in mandibular advancement device treatment for obstructive sleep apnoea: observational cohort study.

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Comparison of success criteria based on long-term symptoms and new-onset hypertension in mandibular advancement device treatment for obstructive sleep apnoea: observational cohort study.

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