Evaluation of the masticatory muscle function, physiological sleep variables, and salivary parameters after electromechanical therapeutic approaches in adult patients with Down syndrome: a randomized controlled clinical trial.

BACKGROUND: There are many comorbidities associated with Down syndrome (DS), including obstructive sleep apnea (OSA) and masticatory muscle alteration. Muscular hypotonia, in particular, of the masticatory and oropharyngeal muscles is one of the main characteristics of individuals with DS, resulting in impairments of speech, swallowing, and mastication in these individuals. In addition, total or partial obstruction of the airways during sleep can occur due to pharyngeal hypotonia, leading to snoring and to OSA. This progressive respiratory disorder is associated with a high risk of morbidity and mortality in individuals with DS. The aim of this research is to assess the therapeutic effects of surface neuromuscular electrical stimulation (NMES), the mastication apparatus (MA), and a mandibular advancement oral appliance (OAm) with an embedded thermosensitive microchip on the functions of masticatory muscles (bilateral masseter and temporal muscles), physiological sleep variables, and salivary parameters in adult patients with DS. METHODS: The patients with DS will be randomly selected and divided into three groups (DS-NMES, DS-MA, and DS-OAm) with a minimum of 10 patients in each group. A thermosensitive microchip will be embedded in the OAm to record its compliance. The therapeutic effects on masticatory muscle function will be investigated through electromyography, a caliper, and a force-transducer device; the sleep variables, in turn, will be evaluated by means of polysomnography. The physicochemical and microbiological properties of the saliva will also be analyzed, including the salivary flow, viscosity, buffer capacity, cortisol levels (susceptibility to psychological and/or physical stress), and Pseudomonas aeruginosa levels (risk of aspiration pneumonia) in these patients. The methods determined for this study will be carried out prior to and after 2 months of the recommended therapies. DISCUSSION: The primary outcomes would be the improvement and/or reestablishment of the function of masticatory muscles and the physiological sleep variables in this target public since individuals with DS commonly present generalized muscular hypotonia and dysfunction of the oropharyngeal musculature. As a secondary outcome indicator, the impact of the applied therapies (NMES, MA, and OAm) on the salivary microbiological and physicochemical properties in DS individuals will also be assessed. Furthermore, the compliance of OAm usage will be measured through a thermosensitive microchip. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clínicos, RBR-3qp5np . Registered on 20 February 2018.

Sleep disorders in patients with myasthenia gravis: a systematic review.

[Purpose] This systematic review evaluated the presence of sleep-disordered breathing in patients with myasthenia gravis and clarified the role of physiotherapy. [Subjects and Methods] We followed the PRISMA declaration criteria. The evaluation was performed in accordance with the STROBE statement for observational and cross-sectional studies and the CONSORT checklist for clinical trials. Searches were followed by hand on MEDLINE, EMBASE, SciELO, PubMed Central, and the Cochrane Central Register of Controlled Trials. [Results] Our searches yielded a total of 36 studies published between 1970 and 2014. The number of patients involved ranged from 9-490. Of the 36 studies, 19 articles were excluded because they did not meet the inclusion criteria. Therefore, 17 observational, cross-sectional, or clinical studies assessing the quality of sleep and prevalence of sleep disorders in patients with myasthenia gravis were eligible for our review. [Conclusion] Some studies of patients with MG show that patients with MG are associated with poor sleep quality, excessive daytime sleepiness, presence of restless syndrome, and a higher incidence of SDB, while other studies do not report such associations. Therefore, given the current inconclusive evidence and limited literature, further study of sleep disturbances in patients with MG is needed.

Obstructive sleep apnea and pulmonary function in patients with severe obesity before and after bariatric surgery: a randomized clinical trial.

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/m(2). 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).

Observational study on efficacy of negative expiratory pressure test proposed as screening for obstructive sleep apnea syndrome among commercial interstate bus drivers--protocol study.

BACKGROUND: Obstructive sleep apnea (OSA) is a respiratory disease characterized by the collapse of the extrathoracic airway and has important social implications related to accidents and cardiovascular risk. The main objective of the present study was to investigate whether the drop in expiratory flow and the volume expired in 0.2 s during the application of negative expiratory pressure (NEP) are associated with the presence and severity of OSA in a population of professional interstate bus drivers who travel medium and long distances. METHODS/DESIGN: An observational, analytic study will be carried out involving adult male subjects of an interstate bus company. Those who agree to participate will undergo a detailed patient history, physical examination involving determination of blood pressure, anthropometric data, circumference measurements (hips, waist and neck), tonsils and Mallampati index. Moreover, specific questionnaires addressing sleep apnea and excessive daytime sleepiness will be administered. Data acquisition will be completely anonymous. Following the medical examination, the participants will perform a spirometry, NEP test and standard overnight polysomnography. The NEP test is performed through the administration of negative pressure at the mouth during expiration. This is a practical test performed while awake and requires little cooperation from the subject. In the absence of expiratory flow limitation, the increase in the pressure gradient between the alveoli and open upper airway caused by NEP results in an increase in expiratory flow. DISCUSSION: Despite the abundance of scientific evidence, OSA is still underdiagnosed in the general population. In addition, diagnostic procedures are expensive, and predictive criteria are still unsatisfactory. Because increased upper airway collapsibility is one of the main determinants of OSA, the response to the application of NEP could be a predictor of this disorder. With the enrollment of this study protocol, the expectation is to encounter predictive NEP values for different degrees of OSA in order to contribute toward an early diagnosis of this condition and reduce its impact and complications among commercial interstate bus drivers. TRIAL REGISTRATION: Registro Brasileiro de Ensaios Clinicos (local acronym RBEC) [Internet]: Rio de Janeiro (RJ): Instituto de Informaçao Cientifica e Tecnologica em Saude (Brazil); 2010 - Identifier RBR-7dq5xx. Cross-sectional study on efficacy of negative expiratory pressure test proposed as screening for obstructive sleep apnea syndrome among commercial interstate bus drivers; 2011 May 31 [7 pages]. Available from http://www.ensaiosclinicos.gov.br/rg/RBR-7dq5xx/.