NCT01315535

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 23, 2011

Status Verified

March 1, 2011

Enrollment Period

9 months

First QC Date

March 14, 2011

Last Update Submit

June 21, 2011

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Mandibular AdvancementOral ApplianceTMD

Study Arms (4)

Fast Titration

Regular Titration

Fast Tritation Including Mandibular Exercises

Regular Tritation Including Mandibular Exercises

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • BMI ≤ 35kg/m2
  • MILD TO MODERATE OSAS DIAGNOSIS ACCORDING TO THE AASM CRITERIA (2005)
  • Negative TMD diagnosis (according to RDC/TMD)

You may not qualify if:

  • DENTAL CONDITIONS THAT CONTRAINDICATED THE ORAL APLLIANCE USAGE
  • SLEEP DISORDERS OTHER THAN OSAS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Do Sono / Universidade Federal de São Paulo

São Paulo, São Paulo, 04039-032, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2013

Last Updated

June 23, 2011

Record last verified: 2011-03

Locations

BR(1)