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

Detalhes bibliográficos
Autor(a) principal: Giannasi, Lilian Chrystiane [UNESP]
Data de Publicação: 2019
Outros Autores: Dutra, Marignês T. S. [UNESP], Tenguan, Vera L. S. [UNESP], Mancilha, Gabriela P. [UNESP], Silva, Gabriela R. C. [UNESP], Fillietaz-Bacigalupo, Elaine [UNESP], Da Silva, Daniel B. [UNESP], Politti, Fabiano, Nacif, Sergio R., De Oliveira, Ezequiel F., Da Rocha, João C., Rocha, Carolina T. [UNESP], Romero, Mateus M. [UNESP], De Oliveira, Claudia S., De Oliveira, Luis V. F., De Mello Rode, Sigmar [UNESP], Koga-Ito, Cristiane Yumi [UNESP], Amorim, Jose B. O. [UNESP], Salgado, Miguel A. C. [UNESP], Gomes, Mônica F. [UNESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1186/s13063-019-3300-0
http://hdl.handle.net/11449/190256
Resumo: 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 (OA m ) 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-OA m ) with a minimum of 10 patients in each group. A thermosensitive microchip will be embedded in the OA m 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 OA m ) on the salivary microbiological and physicochemical properties in DS individuals will also be assessed. Furthermore, the compliance of OA m usage will be measured through a thermosensitive microchip. Trial registration: Registro Brasileiro de Ensaios Clínicos, RBR-3qp5np. Registered on 20 February 2018.
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spelling 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 trialCortisolDown syndromeElectromyographyMasticatory musclesOral appliancePolysomnographySalivaSleep apneaBackground: 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 (OA m ) 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-OA m ) with a minimum of 10 patients in each group. A thermosensitive microchip will be embedded in the OA m 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 OA m ) on the salivary microbiological and physicochemical properties in DS individuals will also be assessed. Furthermore, the compliance of OA m usage will be measured through a thermosensitive microchip. Trial registration: Registro Brasileiro de Ensaios Clínicos, RBR-3qp5np. Registered on 20 February 2018.Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE) Institute of Science and Technology São José Dos Campos Campus São Paulo State University - UNESP, R: Esperança 265Metropolitan University of SantosUniversity Center of Anápolis - UniEvangélicaNove de Julho UniversityHospital Do Servidor Público Estadual de São Paulo (IAMSPE-HSPE)Discipline of Pediatric Dentistry Institute of Science and TechnologyCenter of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE) Institute of Science and Technology São José Dos Campos Campus São Paulo State University - UNESP, R: Esperança 265Universidade Estadual Paulista (Unesp)Metropolitan University of SantosUniversity Center of Anápolis - UniEvangélicaNove de Julho UniversityHospital Do Servidor Público Estadual de São Paulo (IAMSPE-HSPE)Discipline of Pediatric Dentistry Institute of Science and TechnologyGiannasi, Lilian Chrystiane [UNESP]Dutra, Marignês T. S. [UNESP]Tenguan, Vera L. S. [UNESP]Mancilha, Gabriela P. [UNESP]Silva, Gabriela R. C. [UNESP]Fillietaz-Bacigalupo, Elaine [UNESP]Da Silva, Daniel B. [UNESP]Politti, FabianoNacif, Sergio R.De Oliveira, Ezequiel F.Da Rocha, João C.Rocha, Carolina T. [UNESP]Romero, Mateus M. [UNESP]De Oliveira, Claudia S.De Oliveira, Luis V. F.De Mello Rode, Sigmar [UNESP]Koga-Ito, Cristiane Yumi [UNESP]Amorim, Jose B. O. [UNESP]Salgado, Miguel A. C. [UNESP]Gomes, Mônica F. [UNESP]2019-10-06T17:07:17Z2019-10-06T17:07:17Z2019-04-11info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://dx.doi.org/10.1186/s13063-019-3300-0Trials, v. 20, n. 1, 2019.1745-6215http://hdl.handle.net/11449/19025610.1186/s13063-019-3300-02-s2.0-8506418944765435631614034210000-0002-2416-2173Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengTrialsinfo:eu-repo/semantics/openAccess2022-03-16T01:35:26Zoai:repositorio.unesp.br:11449/190256Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T17:49:22.014773Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Giannasi, Lilian Chrystiane [UNESP]
Cortisol
Down syndrome
Electromyography
Masticatory muscles
Oral appliance
Polysomnography
Saliva
Sleep apnea
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author Giannasi, Lilian Chrystiane [UNESP]
author_facet Giannasi, Lilian Chrystiane [UNESP]
Dutra, Marignês T. S. [UNESP]
Tenguan, Vera L. S. [UNESP]
Mancilha, Gabriela P. [UNESP]
Silva, Gabriela R. C. [UNESP]
Fillietaz-Bacigalupo, Elaine [UNESP]
Da Silva, Daniel B. [UNESP]
Politti, Fabiano
Nacif, Sergio R.
De Oliveira, Ezequiel F.
Da Rocha, João C.
Rocha, Carolina T. [UNESP]
Romero, Mateus M. [UNESP]
De Oliveira, Claudia S.
De Oliveira, Luis V. F.
De Mello Rode, Sigmar [UNESP]
Koga-Ito, Cristiane Yumi [UNESP]
Amorim, Jose B. O. [UNESP]
Salgado, Miguel A. C. [UNESP]
Gomes, Mônica F. [UNESP]
author_role author
author2 Dutra, Marignês T. S. [UNESP]
Tenguan, Vera L. S. [UNESP]
Mancilha, Gabriela P. [UNESP]
Silva, Gabriela R. C. [UNESP]
Fillietaz-Bacigalupo, Elaine [UNESP]
Da Silva, Daniel B. [UNESP]
Politti, Fabiano
Nacif, Sergio R.
De Oliveira, Ezequiel F.
Da Rocha, João C.
Rocha, Carolina T. [UNESP]
Romero, Mateus M. [UNESP]
De Oliveira, Claudia S.
De Oliveira, Luis V. F.
De Mello Rode, Sigmar [UNESP]
Koga-Ito, Cristiane Yumi [UNESP]
Amorim, Jose B. O. [UNESP]
Salgado, Miguel A. C. [UNESP]
Gomes, Mônica F. [UNESP]
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade Estadual Paulista (Unesp)
Metropolitan University of Santos
University Center of Anápolis - UniEvangélica
Nove de Julho University
Hospital Do Servidor Público Estadual de São Paulo (IAMSPE-HSPE)
Discipline of Pediatric Dentistry Institute of Science and Technology
dc.contributor.author.fl_str_mv Giannasi, Lilian Chrystiane [UNESP]
Dutra, Marignês T. S. [UNESP]
Tenguan, Vera L. S. [UNESP]
Mancilha, Gabriela P. [UNESP]
Silva, Gabriela R. C. [UNESP]
Fillietaz-Bacigalupo, Elaine [UNESP]
Da Silva, Daniel B. [UNESP]
Politti, Fabiano
Nacif, Sergio R.
De Oliveira, Ezequiel F.
Da Rocha, João C.
Rocha, Carolina T. [UNESP]
Romero, Mateus M. [UNESP]
De Oliveira, Claudia S.
De Oliveira, Luis V. F.
De Mello Rode, Sigmar [UNESP]
Koga-Ito, Cristiane Yumi [UNESP]
Amorim, Jose B. O. [UNESP]
Salgado, Miguel A. C. [UNESP]
Gomes, Mônica F. [UNESP]
dc.subject.por.fl_str_mv Cortisol
Down syndrome
Electromyography
Masticatory muscles
Oral appliance
Polysomnography
Saliva
Sleep apnea
topic Cortisol
Down syndrome
Electromyography
Masticatory muscles
Oral appliance
Polysomnography
Saliva
Sleep apnea
description 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 (OA m ) 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-OA m ) with a minimum of 10 patients in each group. A thermosensitive microchip will be embedded in the OA m 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 OA m ) on the salivary microbiological and physicochemical properties in DS individuals will also be assessed. Furthermore, the compliance of OA m usage will be measured through a thermosensitive microchip. Trial registration: Registro Brasileiro de Ensaios Clínicos, RBR-3qp5np. Registered on 20 February 2018.
publishDate 2019
dc.date.none.fl_str_mv 2019-10-06T17:07:17Z
2019-10-06T17:07:17Z
2019-04-11
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1186/s13063-019-3300-0
Trials, v. 20, n. 1, 2019.
1745-6215
http://hdl.handle.net/11449/190256
10.1186/s13063-019-3300-0
2-s2.0-85064189447
6543563161403421
0000-0002-2416-2173
url http://dx.doi.org/10.1186/s13063-019-3300-0
http://hdl.handle.net/11449/190256
identifier_str_mv Trials, v. 20, n. 1, 2019.
1745-6215
10.1186/s13063-019-3300-0
2-s2.0-85064189447
6543563161403421
0000-0002-2416-2173
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Trials
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
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