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

NCT ID: NCT01315535

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fast Titration

No interventions assigned to this group

Regular Titration

No interventions assigned to this group

Fast Tritation Including Mandibular Exercises

No interventions assigned to this group

Regular Tritation Including Mandibular Exercises

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role lead

Responsible Party

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UNIFESP

Locations

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Instituto Do Sono / Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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LIA BITTENCOURT, PhD

Role: primary

055-11-8234-1166

PAULO CUNALI, PhD

Role: backup

055-41-96868668

Other Identifiers

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CEP0301/10

Identifier Type: -

Identifier Source: org_study_id

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