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Rationale: Approximately 60% of the patients with obstructive sleep apnoea suffer from a positional effect, and approximately 25% of these patients present events only in the supine position.Objective: To validate a new positional vibrating device and evaluate its efficacy in reducing the Apnoea-Hypopnoea Index and the total sleep time in the supine position without disturbing sleep.Methods: A total of 128 patients were recruited for this multicentre, prospective, parallel, randomised controlled trial and were distributed in three arms (general recommendations, inactive and active device). Full overnight polysomnography was performed at baseline and at 12 weeks. Anthropometric variables and sleep and quality of life questionnaires were collected at 4, 8 and 12 weeks.Results: The Apnoea-Hypopnoea Index decreased from 30.6 per hour to 20.4 per hour (p<0.001) in the active device (AD) group. In this group the reduction was 2.3-fold and 3.3-fold than the ones in the general recommendations (GR) and inactive device (ID) groups, respectively (p=0.014). Sleep time in supine position decreased 17.7%±26.3% in GR group (p<0.001), 13.0%±22.4% with ID group (p<0.001) and 21.0%±25.6% in the AD group (p<0.001). Furthermore, total sleep time increased significantly only in the AD group (22.1±57.5 min, p=0.016), with an increased percentage of time in the N3 (deep sleep) and N3+REM (rapid eye movement) stages, without sleep fragmentation.Conclusion: The device was effective in reducing the Apnoea-Hypopnoea Index and time spent in the supine position also in improving sleep architecture. Therefore, the device could be a good option for the management of patients with positional obstructive sleep apnoea.Trial Registration Details: The trial was registered at www.clinicaltrials.gov (NCT03336515). [ABSTRACT FROM AUTHOR]

Background: Obesity hypoventilation syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities.Objectives: We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure.Methods: Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed.Results: In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91-3.14) years for NIV group and 3.00 (2.92-3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups.Conclusion: CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA.Trial Registration Number: NCT01405976. [ABSTRACT FROM AUTHOR]

Background: Sleep disorders are associated with overweight and obese children, and could decrease life quality with limitations to normal daily activities. The purpose of the study is to describe the prevalence of sleep disorders in a cohort of overweight/obese children using respiratory polygraphy. Methods: A descriptive cross-sectional study was conducted in Granada (Spain) on a sample of 98 children with overweight or obesity. The presence of sleep disorders was determined by respiratory polygraphy. Results: Regarding apnoea-hypopnea-index (AHI) results, 44% of affected children had severe sleep apnoea-hypopnea syndrome (SAHS), and the remaining 56% had a mild form of the disorder. With respect to oxygen-desaturation index, 56% of the same group had severe SAHS, 32% had mild SAHS, and the remaining 12% did not suffer from SAHS. Among participants, average scores of 13.8 obstructive apnoea, 7.7 central apnoea, and 13.6 hypopnoea were recorded. Conclusions: Respiratory polygraphy can provide conclusive results in the diagnosis of SAHS in overweight/obese children. Interventional programmes designed and implemented to reduce overweight and obesity can improve quality of sleep and life in children.

Rationale: Despite a significant association between obesity hypoventilation syndrome (OHS) and cardiac dysfunction, no randomised trials have assessed the impact of non-invasive ventilation (NIV) or CPAP on cardiac structure and function assessed by echocardiography., Objectives: We performed a secondary analysis of the data from the largest multicentre randomised controlled trial of OHS (Pickwick project, n=221) to determine the comparative efficacy of 2 months of NIV (n=71), CPAP (n=80) and lifestyle modification (control group, n=70) on structural and functional echocardiographic changes., Methods: Conventional transthoracic two-dimensional and Doppler echocardiograms were obtained at baseline and after 2 months. Echocardiographers at each site were blinded to the treatment arms. Statistical analysis was performed using intention-to-treat analysis., Results: At baseline, 55% of patients had pulmonary hypertension and 51% had evidence of left ventricular hypertrophy. Treatment with NIV, but not CPAP, lowered systolic pulmonary artery pressure (-3.4 mm Hg, 95% CI -5.3 to -1.5; adjusted P=0.025 vs control and P=0.033 vs CPAP). The degree of improvement in systolic pulmonary artery pressure was greater in patients treated with NIV who had pulmonary hypertension at baseline (-6.4 mm Hg, 95% CI -9 to -3.8). Only NIV therapy decreased left ventricular hypertrophy with a significant reduction in left ventricular mass index (-5.7 g/m 2 ; 95% CI -11.0 to -4.4). After adjusted analysis, NIV was superior to control group in improving left ventricular mass index (P=0.015). Only treatment with NIV led to a significant improvement in 6 min walk distance (32 m; 95% CI 19 to 46)., Conclusion: In patients with OHS, medium-term treatment with NIV is more effective than CPAP and lifestyle modification in improving pulmonary hypertension, left ventricular hypertrophy and functional outcomes. Long-term studies are needed to confirm these results., Trial Registration Number: Pre-results, NCT01405976 (https://clinicaltrials.gov/)., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: To evaluate whether follow-up of patients with obstructive sleep apnoea (OSA) undergoing CPAP treatment could be performed in primary care (PC) settings., Design: Non-inferiority, randomised, prospective controlled study., Settings: Sleep unit (SU) at the University Hospital and in 8 PC units in Lleida, Spain., Participants: Patients with OSA were randomised to be followed up at the SU or PC units over a 6-month period., Main Outcomes Measured: The primary outcome was CPAP compliance at 6 months. The secondary outcomes were Epworth Sleep Scale (ESS) score, EuroQoL, patient satisfaction, body mass index (BMI), blood pressure and cost-effectiveness., Results: We included 101 patients in PC ((mean±SD) apnoea-hypopnoea index (AHI) 50.8±22.9/h, age 56.2±11 years, 74% male) and 109 in the SU (AHI 51.4±24.4/h, age 55.8±11 years, 77% male)). The CPAP compliance was (mean (95% CI) 4.94 (4.47 to 5.5) vs 5.23 (4.79 to 5.66) h, p=0.18) in PC and SU groups, respectively. In the SU group, there were greater improvements in ESS scores (mean change 1.79, 95% CI +0.05 to +3.53, p=0.04) and patient satisfaction (-1.49, 95% CI -2.22 to -0.76); there was a significant mean difference in BMI between the groups (0.57, 95% CI +0.01 to +1.13, p=0.04). In the PC setting, there was a cost saving of 60%, with similar effectiveness, as well as a decrease in systolic blood pressure (-5.32; 95% CI -10.91 to +0.28, p=0.06)., Conclusions: For patients with OSA, treatment provided in a PC setting did not result in worse CPAP compliance compared with a specialist model and was shown to be a cost-effective alternative., Trial Registration Number: Clinical Trials NCT01918449., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)