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Effect of neuromuscular electrical stimulation and oral appliances therapies on sleep variables, masticatory function and salivary parameters
Muscle hypotonia is the main feature of Down’s syndrome (DS) that leads to impairment in oropharynx muscles. The hypotonia of the pharynx will favor a complete or partial obstruction of the upper airway during sleep, resulting in snoring and obstructive sleep apnea (OSA), which is a progressive and life-threatening disease associated to a high morbidity and mortality in DS individuals.
To evaluate the efficacy of mandibular advancement oral appliance OAm with embbeded thermosensitive microchip and neuromuscular electrical stimulation (NMES) on sleep parameters, masticatory muscles and salivary status, through polysomnography (PSG), surface electromyography (sEMG) and salivary tests.
This project is a randomized clinical trial to evaluate the effects of mandibular advancement oral appliance (AIOm), a specific device to treat sleep disorders breathing, with a thermosensitive microchip, and masseter/temporalis neuromuscular electrical stimulation (NMES) therapies on sleep respiratory disorders, physiologic sleep variables, muscle electrical activity, and salivary parameters. Adults with DS is enrolled in this study. Epworth Sleep Scale (ESE), STOP-BANG and Fletcher & Luckett questionnaires will be answered by caregivers. A portable PSG type II system (Embla Embletta MPR+PG ST+Proxy, Natus, California-USA) for a full-sleep study at patients’ home, sEMG and salivary tests will be performed prior the therapies and after 2 month-period. Adults with DS and respiratory sleep disorders will be randomly distributed into 2 groups (DS-NMES and DS-OAm) with at least 10 participants in each group. The inclusion criteria included the presence of symptoms of OSA, parcial preserved cognitive function to respond to verbal commands and informed and written consent given by caregivers. The exclusion criteria was BMI > 35 Kg/m2 and 10< age >40.
Primary outcome would be the improvement on physiologic sleep variables which are influenced by anatomic alteration and by a compromised physiological pattern of the oropharynx muscles. As secondary outcome an improvement/recovery of masticatory function, once the hypotonia is an inherent feature among these individuals, as well as it will be possible to measure the OAm objective adherence and the impact of the therapies on salivary parameters in adults DS individuals.
The results will be useful to bring new therapies, as non invasive options, for adult with Down syndrome.
Down syndrome; sleep apnea; polysomnography; oral appliance; NMEE
Centro Universitário de Anapólis Uni-Evangélica - Goias - Brasil, Hospital do Servidor Público Estadual de São Paulo-IAMSPE-HSPE - Sao Paulo - Brasil, ICT-UNESP/SJC - Sao Paulo - Brasil
Lilian Chrystiane Giannasi, Marignes ST Dutra, Sergio Roberto Nacif, Ezequiel Fernandes Oliveira, Luis Vicente Franco Oliveira, Jose Benedito Oliveira Amorim, Miguel Angel Castillo Salgado, Monica Fernandes Gomes