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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12610000306011
Ethics application status
Approved
Date submitted
12/04/2010
Date registered
16/04/2010
Date last updated
16/04/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electromyographic study of facial muscles in nasal and oral – vicious and obstructive -breathing children
Scientific title
Electromyography of facial muscles in nasal and oral (vicious and obstructive) breathing children
Secondary ID [1] 1606 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mouth breathing syndrome 257137 0
Condition category
Condition code
Respiratory 257294 257294 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 (masseter, temporal and upper and lower mouth orbicular muscles during rest and isommetry of labial and masticatory muscles. The duration of the EMG was about an hour. Each signal was recorded during 10 seconds.
Intervention code [1] 256293 0
Diagnosis / Prognosis
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] 258199 0
The outcomes showed that the EMG activity did not differ between nasal and mouth breathers. The respiratory mode did not interfere in the muscular activity behavior.
Timepoint [1] 258199 0
The evaluation of the children was performed during three months and the outocomes was obtained after this period.
Secondary outcome [1] 263849 0
Nil
Timepoint [1] 263849 0
Nil

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?
No
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
Case control
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] 2582 0
Brazil
State/province [1] 2582 0

Funding & Sponsors
Funding source category [1] 256791 0
Self funded/Unfunded
Name [1] 256791 0
Luane Boton
Country [1] 256791 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] 256067 0
Individual
Name [1] 256067 0
Ana Maria Toniolo da Silva
Address [1] 256067 0
Federal University of Santa Maria, Department of Speech Therapy, campus, km 09 highway, Camobi, Santa Maria, RS, CEP 97119000
Country [1] 256067 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of the study was to verify the muscular activity of facial muscles of nasal and mouth breathing children, and compare them, in order to improve the diagnosis and therapeutic intervention for this problem.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31037 0
Address 31037 0
Country 31037 0
Phone 31037 0
Fax 31037 0
Email 31037 0
Contact person for public queries
Name 14284 0
Luane Boton
Address 14284 0
Avenida Medianeira 1040/503, Santa Maria, RS, CEP 970060-003
Country 14284 0
Brazil
Phone 14284 0
55-55-32221757
Fax 14284 0
Email 14284 0
[email protected]
Contact person for scientific queries
Name 5212 0
Luane Boton
Address 5212 0
Avenida Medianeira 1040/503, Santa Maria, RS, CEP 970060-003
Country 5212 0
Brazil
Phone 5212 0
55-55-32221757
Fax 5212 0
Email 5212 0
[email protected]

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.