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
  Purpose

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.


Condition
Obstructive Sleep Apnea Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fast Titration
Regular Titration
Fast Tritation Including Mandibular Exercises
Regular Tritation Including Mandibular Exercises

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315535

Locations
Brazil
Instituto Do Sono / Universidade Federal de São Paulo Recruiting
São Paulo, Brazil, 04039-032
Contact: LIA BITTENCOURT, PhD    055-11-8234-1166    lia@pscicobio.epm.br   
Contact: PAULO CUNALI, PhD    055-41-96868668    pacunali@onda.com.br   
Principal Investigator: LIA BITTENCOURT, PhD         
Sub-Investigator: PAULO CUNALI, PhD         
Sponsors and Collaborators
Associacao Fundo de Incentivo a Psicofarmcologia
  More Information

No publications provided

Responsible Party: BITTENCOURT, LIA R. A. / PhD, UNIFESP
ClinicalTrials.gov Identifier: NCT01315535     History of Changes
Other Study ID Numbers: CEP0301/10
Study First Received: March 14, 2011
Last Updated: June 21, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
Mandibular Advancement
Oral Appliance
TMD

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014