Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000357055
Ethics application status
Approved
Date submitted
23/04/2010
Date registered
4/05/2010
Date last updated
4/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tonsil and adenoid obstruction and muscle activity in nasal and oral breathing children
Scientific title
Tonsil and adenoid obstruction and orbicular oris muscle activity in nasal and oral (vicious and obstructive) breathing children
Secondary ID [1] 251658 0
nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adenoid and tonsil obstruction 257239 0
Condition category
Condition code
Respiratory 257376 257376 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Surface Electromyography (EMG) exam of facial muscles (upper and lower mouth orbicular muscles) during rest, suction and swallowing functions and isommetry . The duration of the EMG was about an hour. Each signal was recorded during 10 seconds. The overall duration of this observational study was 8 months.
Intervention code [1] 256418 0
Not applicable
Comparator / control treatment
The data were compared between the control group (nasal breathing children) and study group (mouth breathing children)
Control group
Active

Outcomes
Primary outcome [1] 258287 0
Correlation between the obstruction tonsil and adenoid and the upper and lower mouth orbicular muscles activity as assessed by EMG.
Timepoint [1] 258287 0
The evaluation of the children was performed during three months and the outocomes was obtained after this period.
Secondary outcome [1] 263972 0
nill
Timepoint [1] 263972 0
nill

Eligibility
Key inclusion criteria
children with nasal or mouth (vicious or obstructive) breathing diagnosed by otorhinolaryngologist
Minimum age
7 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
children with signals and symptoms of neurological disease or syndrome, previus facial surgery or malformation, to be in speech therapy or orthodontics treatment.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
59
Accrual to date
Final
Recruitment outside Australia
Country [1] 2601 0
Brazil
State/province [1] 2601 0

Funding & Sponsors
Funding source category [1] 256860 0
Self funded/Unfunded
Name [1] 256860 0
Luane Boton
Country [1] 256860 0
Brazil
Primary sponsor type
Individual
Name
Luane Boton
Address
Federal University of Santa Maria, Department of Speech Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country
Brazil
Secondary sponsor category [1] 256135 0
Individual
Name [1] 256135 0
Ana Maria Toniolo da Silva
Address [1] 256135 0
Federal University of Santa Maria, Department of Speech Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country [1] 256135 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of the study was to verify the repercussion of the tonsil and adenoid obstruction on the oral muscles function, which act in the lip sealing. The function of these muscles also influences the respiratory mode (nasal or mouth breathing).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31088 0
Address 31088 0
Country 31088 0
Phone 31088 0
Fax 31088 0
Email 31088 0
Contact person for public queries
Name 14335 0
Luane Boton
Address 14335 0
Federal University of Santa Maria, Department of Speech Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country 14335 0
Brazil
Phone 14335 0
55-32209832
Fax 14335 0
Email 14335 0
luaneboton@yahoo.com.br
Contact person for scientific queries
Name 5263 0
Luane Boton
Address 5263 0
Federal University of Santa Maria, Department of Speech Therapy, campus, KM 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country 5263 0
Brazil
Phone 5263 0
55-32209832
Fax 5263 0
Email 5263 0
luaneboton@yahoo.com.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.