NCT01315535UnknownNot Applicable
Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome
Associacao Fundo de Incentivo a Psicofarmcologia1 site in 1 country120 target enrollmentStarted: March 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
Study Sites (1)
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