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NCT01315535 Clinical Trial

Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:
Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01315535
Other study ID # CEP0301/10
Secondary ID
Status Recruiting
Phase N/A
First received March 14, 2011
Last updated June 21, 2011
Start date March 2011
Est. completion date December 2013

Study information
Verified date March 2011
Source Associacao Fundo de Incentivo a Psicofarmcologia
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial Summary

The literature does not discuss if the fast oral appliance titration (30 days period) in Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important side effects observed in OSAS treatment with oral appliance. Since the effectiveness of mandibular exercises in the control of TMD pain has already been verified, it may play a fundamental role in the support of the fast oral appliance titration.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2013
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

- BMI = 35kg/m2

- MILD TO MODERATE OSAS DIAGNOSIS ACCORDING TO THE AASM CRITERIA (2005)

- Negative TMD diagnosis (according to RDC/TMD)

Exclusion Criteria:

- DENTAL CONDITIONS THAT CONTRAINDICATED THE ORAL APLLIANCE USAGE

- SLEEP DISORDERS OTHER THAN OSAS

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Instituto Do Sono / Universidade Federal de São Paulo São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Associacao Fundo de Incentivo a Psicofarmcologia

Country where clinical trial is conducted

Brazil, 

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