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

This study is currently recruiting participants.

Verified March 2011 by Associacao Fundo de Incentivo a Psicofarmcologia

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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2011
Last Updated Date	June 21, 2011
Start Date ^ICMJE	March 2011
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01315535 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment
Official Title ^ICMJE	Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Subjects diagnosed with mild to moderate osas, according to the aasm criteria (2005) from the respiratory disorders clinic (UNIFESP) referred to oral appliance treatment.
Condition ^ICMJE	Obstructive Sleep Apnea Syndrome
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Fast Titration Regular Titration Fast Tritation Including Mandibular Exercises Regular Tritation Including Mandibular Exercises
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	120
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	19 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Brazil

Administrative Information
NCT Number ^ICMJE	NCT01315535
Other Study ID Numbers ^ICMJE	CEP0301/10
Has Data Monitoring Committee	No
Responsible Party	BITTENCOURT, LIA R. A. / PhD, UNIFESP
Study Sponsor ^ICMJE	Associacao Fundo de Incentivo a Psicofarmcologia
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Associacao Fundo de Incentivo a Psicofarmcologia
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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