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:
Associacao Fundo de Incentivo a Psicofarmcologia
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
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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
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 Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013