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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT01315535
First received: March 14, 2011
Last updated: June 21, 2011
Last verified: March 2011

March 14, 2011
June 21, 2011
March 2011
December 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01315535 on ClinicalTrials.gov Archive Site
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Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment
Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Subjects diagnosed with mild to moderate osas, according to the aasm criteria (2005) from the respiratory disorders clinic (UNIFESP) referred to oral appliance treatment.

Obstructive Sleep Apnea Syndrome
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  • Fast Titration
  • Regular Titration
  • Fast Tritation Including Mandibular Exercises
  • Regular Tritation Including Mandibular Exercises
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2013
December 2011   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
No
Not Provided
Brazil
 
NCT01315535
CEP0301/10
No
BITTENCOURT, LIA R. A. / PhD, UNIFESP
Associacao Fundo de Incentivo a Psicofarmcologia
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Associacao Fundo de Incentivo a Psicofarmcologia
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP