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

• Conditions: Obstructive Sleep Apnea Syndrome

• Registration Number: NCT01315535
• Lead Sponsor: Associacao Fundo de Incentivo a Psicofarmcologia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-03
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-23
• Primary Completion: 2011-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Instituto Do Sono / Universidade Federal de São Paulo; 🇧🇷 São Paulo, Brazil