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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-93ggrm
Enrollment
Unknown
Registered
2012-01-04
Start date
2011-10-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea, carotid atherosclerose.

Interventions

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 app
device
procedure/surgery
E01.370.520.625
E01.370.350.850
E01.370.350.850.850.860
E01.370.600.875.500

Sponsors

UNINOVE -Universidade Nove de Julho- São Paulo - SP
Lead Sponsor
UNINOVE -Universidade Nove de Julho- São Paulo - SP
Collaborator

Eligibility

Inclusion criteria

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

Exclusion criteria: Psychiatric deseases, use fo any drugs that interfer in sleep, severe temporomandibular dysfunction.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Polysomnogram to evaluate and compare the effect of oral appliance e placebo for other sleep variables.—

Countries

Brazil

Contacts

Public ContactLuis ;luis Vicente Franco de Oliveira;de Oliveira

UNINOVE -Universidade Nove de Julho- São Paulo - SP;UNINOVE -Universidade Nove de Julho- São Paulo - SP

oliveira.lvf@uninove.br;oliveiralvf@uninove.br55 11 91069296;11 36659890

Outcome results

None listed

Source: REBEC (via WHO ICTRP)