Mouth BreathingNCT01296828
Lips and Tongue of Mouth Breathing Children
An observational study of Mouth Breathing, run by Pontificia Universidade Catolica de Sao Paulo at 1 site in Brazil.
Trial summary
Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing children. Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in São Paulo, SP, Brazil . Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth Breathing
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in Instituto CEFAC, São Paulo, SP, Brazil.
Who may be able to join
- Mouth breathing children diagnosed by doctor.
Who cannot join
- Children with mental, neurological or hearing diseases, or with cold or flu at the examination day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posture, Tone and Mobility of Lips and Tongue of Mouth Breathing Children
Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing children.
Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth breathing children.
- Conditions
- Mouth Breathing
- Medical subject headings
- Mouth Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MOUTH BREATHING CHILDREN | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Catolica de Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Irene Q Marchesan, Study chair, CEFAC Educação e Saúde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296828
- Sponsor's protocol ID
- CEP PUC/SP 302/2008
- Status last verified
- Nov 2010
- First submitted
- 1 Feb 2011
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture, Tone and Mobility of Lips and Tongue of Mouth Breathing Children
- ClinicalTrials.gov ID
- NCT01296828
- Acronym / sponsor ID
- CEP PUC/SP 302/2008
- Conditions
- Mouth Breathing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pontificia Universidade Catolica de Sao PauloUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- May 2011 (estimated)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: to characterize the posture, tone and mobility of lips and tongue of mouth breathing children.
Methods: 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in São Paulo, SP, Brazil . It was used the MBGR protocol to evaluate the posture, tone and mobility of lips and tongue of mouth breathing children.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOUTH BREATHING CHILDREN | – | – |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 40 mouth breathing children, 26 (65%) male and 14 (35%) female, aging between 7 and 10 years old, were involved in this research realized in Instituto CEFAC, São Paulo, SP, Brazil.
Key inclusion criteria (1 listed)
- Mouth breathing children diagnosed by doctor.
Key exclusion criteria (1 listed)
- Children with mental, neurological or hearing diseases, or with cold or flu at the examination day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Q Marchesan study chair
CEFAC Educação e Saúde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mouth Breathing, run by Pontificia Universidade Catolica de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2011.