Obstructive sleep apnea and pulmonary function in morbid obesity before and after bariatric surgery: a randomized controlled clinical trial

2013 ◽  
Vol 14 ◽  
pp. e223 ◽  
Author(s):  
I. Aguiar ◽  
I. Santos ◽  
S. Nacif ◽  
W. Freitas Junior ◽  
C. Malheiros ◽  
...  
2014 ◽  
Vol 9 ◽  
Author(s):  
Isabella C. Aguiar ◽  
Wilson R. Freitas jr. ◽  
Israel R. Santos ◽  
Nadua Apostolico ◽  
Sergio R. Nacif ◽  
...  

Background: The increasing prevalence of obesity in both developed and developing countries is one of the most serious public health problems and has led to a global epidemic. Obesity is one of the greatest risk factors of obstructive sleep apnea (OSA), which is found in 60 to 70% of obese patients mainly due to the buildup of fat tissue in the upper portion of the thorax and neck. The aim of the present randomized clinical trial is to assess daytime sleepiness, sleep architecture and pulmonary function in patients with severe obesity before and after bariatric surgery. Methods: This randomized, controlled trial, was designed, conducted, and reported in accordance with the standards of The CONSORT (Consolidated Standards of Reporting Trials) Statement. Patients were divided into a bariatric surgery group and control group. The clinical evaluation was performed at the Sleep Laboratory of the Nove de JulhoUniversity (Sao Paulo, Brazil) and consisted of the collection of clinical data, weight, height, body mass index (BMI), measurements of neck and abdomen circumferences, spirometry, maximum ventilatory pressure measurements, standard overnight polysomnography (PSG) and the administration of the Berlin Questionnaire and Epworth Sleepiness Scale. Results: Fifty-two patients participated in the present study and performed PSG. Out of these, 16 underwent bariatric surgery. After surgery, mean BMI decreased from 48.15 ± 8.58 to 36.91 ± 6.67 Kg/m2. Significant differences were found between the preoperative and postoperative periods regarding neck (p < 0.001) and waist circumference (p < 0.001), maximum inspiratory pressure (p = 0.002 and p = 0.004) and maximum expiratory pressure (p = 0.001 and p = 0.002) for women and men, respectively, as well as sleep stage N3 (p < 0.001), REM sleep (p = 0.049) and the apnea-hypopnea index (p = 0.008). Conclusions: Bariatric surgery effectively reduces neck and waist circumference, increases maximum ventilatory pressures, enhances sleep architecture and reduces respiratory sleep disorders, specifically obstructive sleep apnea, in patients with severe obesity. Trial registration: The protocol for this study was registered with the World Health Organization (Universal Trial Number: U1111-1121-8873) and Brazilian Registry of Clinical Trials – ReBEC (RBR-9k9hhv).


SLEEP ◽  
2019 ◽  
Vol 42 (6) ◽  
Author(s):  
A Simon Carney ◽  
Nick A Antic ◽  
Peter G Catcheside ◽  
Ching Li Chai-Coetzer ◽  
Peter A Cistulli ◽  
...  

Abstract Study Objectives Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA. Methods A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months. Results Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea–hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group). Conclusions The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. Clinical Trial Registration Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.


2012 ◽  
Vol 13 (3) ◽  
pp. 290-296 ◽  
Author(s):  
Lucia Sukys-Claudino ◽  
Walter Moraes ◽  
Christian Guilleminault ◽  
Sergio Tufik ◽  
Dalva Poyares

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