Mouth BreathingNCT01019525
Posture and Pulmonary Function of Mouth-breathing Children
An observational study of Mouth Breathing, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
The purpose of this study is to characterize the posture and respiratory function of mouth-breathing children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth Breathing
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2004to Jun 2008
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Mouth-breathing children were referred by Pediatrics Service (Federal University of Rio de Janeiro) and by School of Dentistry (Federal University of Rio de Janeiro), after the diagnosis of mouth breathing was confirmed. Nasal breathing children were recruited from Tia Ciata Municipal School (Praça Onze-Rio de Janeiro, Brazil).
Who may be able to join
- Nasal breathing (normal subjects group) or mouth breathing (mouth-breathing group), and the age between eight (08) and twelve (12) for both groups.
Who cannot join
- Prior physiotherapeutic treatment or in process, presence of diagnostic or report on acute or chronic pulmonary disease, neurofunctional or cognitive impairment and alteration of the osteomuscular system.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
About this study
The purpose of this study is to characterize the posture and respiratory function of mouth-breathing children.
Read the detailed description
Mouth-breathing children presents changes in stomatognathic system, which results in head projection, tension augment in scapular belt muscles and postural adaptations. Although thoracic shape and posture can influence ventilatory dynamics, we didn't find studies addressing pulmonary function of mouth-breathing children. This was a transversal study, designed to analyze the posture of mouth-breathing children, and verify the existence of correlation between posture and pulmonary volumes.
- Conditions
- Mouth Breathing
- Keywords
- respiration, respiratory disorders, Otolaryngology, Otorhinolaryngology, Posture
- Medical subject headings
- Mouth Breathing, Respiratory Aspiration, Respiration Disorders
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 aged between 8-12 years, with clinical diagnosis of mouth breathing | |
| Nasal Breathing | Children aged between 8-12 years old, with normal breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function, by means of forced spirometry.
Measured: Within the first 30 days after recruitment.
Secondary outcomes (1)
Posture, by means of photogrammetry.
Measured: Within the first 30 days after recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJun 2004
- Primary completionJun 2008
- Study completionJun 2008
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
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Investigators
- Sara LS Menezes, PhD, Study chair, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019525
- Sponsor's protocol ID
- MBPF
- Status last verified
- Nov 2009
- First submitted
- 24 Nov 2009
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture and Pulmonary Function of Mouth-breathing Children
- ClinicalTrials.gov ID
- NCT01019525
- Acronym / sponsor ID
- MBPF
- Conditions
- Mouth Breathing
- Keywords
- respiration, respiratory disorders, Otolaryngology, Otorhinolaryngology, Posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Nov 2009 (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.
The purpose of this study is to characterize the posture and respiratory function of mouth-breathing children.
Detailed description
Mouth-breathing children presents changes in stomatognathic system, which results in head projection, tension augment in scapular belt muscles and postural adaptations. Although thoracic shape and posture can influence ventilatory dynamics, we didn't find studies addressing pulmonary function of mouth-breathing children. This was a transversal study, designed to analyze the posture of mouth-breathing children, and verify the existence of correlation between posture and pulmonary volumes.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouth Breathing | – | –Children aged between 8-12 years, with clinical diagnosis of mouth breathing |
| Nasal Breathing | – | –Children aged between 8-12 years old, with normal breathing |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Mouth-breathing children were referred by Pediatrics Service (Federal University of Rio de Janeiro) and by School of Dentistry (Federal University of Rio de Janeiro), after the diagnosis of mouth breathing was confirmed. Nasal breathing children were recruited from Tia Ciata Municipal School (Praça Onze-Rio de Janeiro, Brazil).
Key inclusion criteria (1 listed)
- Nasal breathing (normal subjects group) or mouth breathing (mouth-breathing group), and the age between eight (08) and twelve (12) for both groups.
Key exclusion criteria (1 listed)
- Prior physiotherapeutic treatment or in process, presence of diagnostic or report on acute or chronic pulmonary disease, neurofunctional or cognitive impairment and alteration of the osteomuscular system.
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
Pulmonary function, by means of forced spirometry.
Time frame: Within the first 30 days after recruitment.
1 secondary outcome
Posture, by means of photogrammetry.
Time frame: Within the first 30 days after recruitment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2009.
Related trials for Mouth Breathing
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Effects of Surgery on Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea
OSA - Obstructive Sleep Apnea, Dysphagia
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.
Sara LS Menezes, PhD study chair
Universidade Federal do Rio de Janeiro
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 Universidade Federal do Rio de Janeiro 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: finished, as of the sponsor's last update on 26 Nov 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Pulmonary function, by means of forced spirometry. (time frame: Within the first 30 days after recruitment.). It is what the study was designed to measure, not a finding.
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 26 Nov 2009.