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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-93ggrm |
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Date of registration:
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04/01/2012 |
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Primary sponsor: |
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Public title:
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Effect of the treatment of oral appliance for obstructive sleep apnea on heart rate variability and on structural and functional characteristics of carotid artery.
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Scientific title:
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Randomized clinical trial, controled, duble blind, four arms, to evaluate the impact of the treatment of oral appliance for obstructive sleep apnea on heart rate variability and on structural and functional characteristics of carotid artery. |
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Date of first enrolment:
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30/10/2011 |
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Target sample size:
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0 |
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Recruitment status: |
other |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-93ggrm/ |
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Study type:
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Study design:
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Randomized clinical trial, duble blind, two arms,
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Countries of recruitment
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Brazil
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Contacts
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Name:
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luis Vicente
de Oliveira |
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Address:
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01156-080
São Paulo
Brazil |
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Telephone:
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11 36659890 |
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Email:
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oliveiralvf@uninove.br |
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Affiliation:
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UNINOVE -Universidade Nove de Julho- São Paulo - SP |
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Name:
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Luis
Franco de Oliveira |
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Address:
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Av Benedito Matarazzo
12243700
São Paulo
Brazil |
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Telephone:
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55 11 91069296 |
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Email:
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oliveira.lvf@uninove.br |
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Affiliation:
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UNINOVE -Universidade Nove de Julho- São Paulo - SP |
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Key inclusion & exclusion criteria
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Inclusion criteria: Man and woman, at list with 20 years old, ody mass index lower than 30, with no co-morbidities, apnea/hipopnea index moderate to severe, opening of 40mm, mandibular protriusion 7mm, periodontal health.
Exclusion criteria: Psychiatric deseases, use fo any drugs that interfer in sleep, severe temporomandibular dysfunction.
Age minimum:
20
Age maximum:
0
Gender:
-
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Health Condition(s) or Problem(s) studied
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Obstructive sleep apnea, carotid atherosclerose.
C08.618.085.852.850
C14.280.647.250.260
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Intervention(s)
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Polysomnography, ecodoppler, heart rate variability prior the study. After, the sample will be divided in 2 groups with 35 subjects, one group will use the placebo and, the other will use the oral appliance to treat sleep apnea.After 6 months, all exams will be done with oral appliance in situ.
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Primary Outcome(s)
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Ecodoppler to evaluate the effect of oral appliance and placebo on carotid distensibility.
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Ecodoppler to evaluate the effect of oral appliance and placebo on carotid tickness.
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Heart rate variability analysis to compare the effect of oral appliance and placebo on autonomic nervous system fuction.
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Polysomnography to evaluate the effect of oral appliance and placebo on apnea/hypopnea index.
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Pulse velocity to evaluate the effect oforal appliance and placebo on carotice stifness.
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Secondary Outcome(s)
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Polysomnogram to evaluate and compare the effect of oral appliance e placebo for other sleep variables.
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Source(s) of Monetary Support
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UNINOVE -Universidade Nove de Julho- São Paulo - SP - Brazil
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