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

A

Associacao Fundo de Incentivo a Psicofarmcologia

Status

Unknown

Conditions

Obstructive Sleep Apnea Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT01315535
CEP0301/10

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 4 patient groups

Fast Titration
Regular Titration
Fast Tritation Including Mandibular Exercises
Regular Tritation Including Mandibular Exercises

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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