Dataset Information

Long-term obstructive sleep apnea therapy: a 10-year follow-up of mandibular advancement device and continuous positive airway pressure.

ABSTRACT:

Study objectives

Obstructive 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.

Methods

This 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.

Results

Polysomnography 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.

Conclusions

Both 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 registration

Registry: 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.

SUBMITTER: Uniken Venema JAM

PROVIDER: S-EPMC7075089 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

Long-term obstructive sleep apnea therapy: a 10-year follow-up of mandibular advancement device and continuous positive airway pressure.

Uniken Venema Julia A M JAM Doff Michiel H J MHJ Joffe-Sokolova Dilyana D Wijkstra Peter J PJ van der Hoeven Johannes H JH Stegenga Boudewijn B Hoekema Aarnoud A

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20200114 3

<h4>Study objectives</h4>Obstructive 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.<h4>Methods</h4>This is a longitudinal follow-up study taken from a subset of ...[more]

PMID: 31992403

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Project description:Study objectivesIt has been suggested that treatment for obstructive sleep apnea (OSA) reduces cardiovascular risk. So far, knowledge is limited about the difference in the reduction of this risk between mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy. The aim of this study was to compare the cardiovascular effects of MAD vs CPAP therapy in patients with moderate OSA.MethodsPatients with an apnea-hypopnea index of 15-30 events/h were randomized to either MAD or CPAP therapy. At baseline and after 12-month follow-up, 24-hour ambulant blood pressure measurements and laboratory measurements were performed. Ambulant blood pressure measurements consisted of 24-hour, daytime and night-time systolic and diastolic blood pressure and heart rate measurements. Laboratory measurements consisted of serum lipid values, creatinine, high-sensitivity C-reactive protein, plasma glucose, hemoglobin A1c glycated hemoglobin, proinflammatory cytokines, soluble receptor for advanced glycation end-products, chemokines, and adhesion molecules.ResultsOf the 85 randomized patients with moderate OSA, data were available for 54 patients (n = 24 MAD, n = 30 CPAP) at 12-month follow-up and showed that apnea-hypopnea index significantly decreased with either therapy. In the MAD group, soluble receptor for advanced glycation end-products and glycated hemoglobin were significantly higher after 12 months' follow-up compared to baseline. No significant changes were found between MAD and CPAP treatments for all outcomes.ConclusionsTreatment of patients with moderate OSA with either MAD or CPAP therapy had no profound effects on major cardiovascular risk factors after 12 months.Clinical trial registrationRegistry: ClinicalTrials.gov; Title: MRA Therapy vs CPAP Therapy in Moderate OSAS; Identifier: NCT01588275; URL: https://clinicaltrials.gov/ct2/show/NCT01588275.CitationUniken Venema JAM, Knol-de Vries GE, van Goor H, Westra J, Hoekema A, Wijkstra PJ. Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2022;18(6)1547-1555.

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.

Dataset Information

Long-term obstructive sleep apnea therapy: a 10-year follow-up of mandibular advancement device and continuous positive airway pressure.

Study objectives

Methods

Results

Conclusions

Clinical trial registration

Publications

Long-term obstructive sleep apnea therapy: a 10-year follow-up of mandibular advancement device and continuous positive airway pressure.

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