Effect of the treatment of oral appliance for obstructive sleep apnea on heart rate variability and on structural and functional characteristics of carotid artery.

Not Applicable

• Conditions: Obstructive sleep apnea, carotid atherosclerose.; C08.618.085.852.850; C14.280.647.250.260

• Registration Number: RBR-93ggrm
• Lead Sponsor: INOVE -Universidade Nove de Julho- São Paulo - SP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: other
• Sex: Not specified
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Polysomnography to evaluate the effect of oral appliance and placebo on apnea/hypopnea index.;Ecodoppler to evaluate the effect of oral appliance and placebo on carotid tickness.;Ecodoppler to evaluate the effect of oral appliance and placebo on carotid distensibility.;Pulse velocity to evaluate the effect oforal appliance and placebo on carotice stifness.;Heart rate variability analysis to compare the effect of oral appliance and placebo on autonomic nervous system fuction.

Secondary Outcome Measures

Name	Time	Method
Polysomnogram to evaluate and compare the effect of oral appliance e placebo for other sleep variables.