Down Syndrome
Conditions
Interventions
Randomized clinical trial including 30 Down syndrome patients with respiratory sleep disorders. Prior the study basal data will be collected, through polysomnography, surface electromyography on masse
Device
E01.370.405.255
E02.331
Sponsors
Instituto de Ciências eTecnologia ICT - Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
Instituto de Ciências eTecnologia ICT - Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
Eligibility
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: Down Syndrome patients; both genders; snoring and mild to moderate apnea/hypoapnea index; cognitive status parcialy preserved; understand the verbal comands necessary to perform this research project; agree to participate by free will and must sign the Awareness Term. Cognitive analysis will be realized under simple comands, such as "open the mouth", "close the mouth", " bite", "relax". If patients be able to answear this simple comands, will be considered as part of the study.
Exclusion criteria
Exclusion criteria: Body mass index grater than 30; unsatisfactory dental health; not able to reach the University when is needed; have been submited to physiotherapic and orthodontic treatment at least 6 months before the begining of this study; present psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of respiratory events per hour of sleep mensured through apnea/hypopnea index (AHI)evaluated through polysomnography to a minimun of AHI=10/h, after usage of the mandibular advancement oral appliance with an attached thermosensitive microchip, after usage of the hiperboloide and surface neuromuscular electrical stimulation therapy.;Improvement of electrical activity of masseter and temporallis bilateral muscles after usage of the mandibular advancement oral appliance with an attached thermosensitive microchip, after usage of the hiperboloide and surface neuromuscular electrical stimulation therapy evaluated through surface electromyography;Statistic analisys of all results in order to see if there is a better therapy, between all treatment applied in this study, that could lead in better improvement on apnea/hypopnea index and oxyhemoglobin dessaturation and on electrical activity of masseter and temporallis bilateral muscles after usage of the mandibular advancement oral appliance with an attached thermosensitive microchip, after the usage of the hiperboloide and surface neuromuscular electrical stimulation therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement on other physiologic sleep variables such as sleep architeture, arousal index and sleep eficiency given in percentage, after usage of the mandibular advancement oral appliance with an attached thermosensitive microchip, after usage of the hiperboloide and surface neuromuscular electrical stimulation therapy evaluated through Polysomnography.;Objective measurement of the mandibular advancement oral appliance usage through the evaluation of the data collected from the thermosensitive microchip attached to the oral appliance. The microchip records the days and hours that patient has used the oral appliance, through a algorithmic installed into the microchip.;Improvement of salivary parameters mensured through cortisol, "pseudomonas aeroginosas" and salivar flow - PH tests given in mililiters (ml), after usage of mandibular advancement oral appliance with an attached thermosensitive microchip, after usage of hiperboloide and after usage of neuromuscular electrical stimulation. | — |
Countries
Brazil
Contacts
Public ContactMonica Gomes
Instituto de Ciências eTecnologia ICT - Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
Outcome results
None listed