Mouth BreathingNCT02437877
The Influence of Breathing in Writing
An observational study of Mouth Breathing, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Purpose: To examine whether nasal breathing influences the perception of sound causing trade between hard and soft consonants in the writing of children in school age and the incidence of trade. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth Breathing
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Jan 2010
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 200 children, 100 previously diagnosed with oronasal breath (51 females and 49 males) who participated in the study group and 100 nasal breathers (54 females and 46 males) which were the control group.
Who may be able to join
- Mouth Breather/Nasal Breather
- Literate
Who cannot join
- Hearing trouble
- Speech trouble
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Mouth Breathing in the Discrimination of Sonority Perception in Writing
Purpose: To examine whether nasal breathing influences the perception of sound causing trade between hard and soft consonants in the writing of children in school age and the incidence of trade.
Read the detailed description
To achieve the above goal explained, it was used:
Methods: The sample was consisted of 200 children, 100 previously diagnosed with oronasal breath (51 females and 49 males) who participated in the study group and 100 nasal breathers (54 females and 46 males) which were the control group. 36 words were dictated as minimal pairs to be written. Then a story was submitted in sequence of six figures from which the subjects produced a text.
- Conditions
- Mouth Breathing
- Keywords
- Respiration, Learning, Speech, Language and Hearing Sciences
- Medical subject headings
- Mouth Breathing, Respiratory Aspiration, Speech, Language
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 Breather | Mouth Breathers Children from 7 to 13 years old | |
| Nasal Breather | Nasal breathers children from 7 to 13 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between production written and directed free nose breathers and mouth breathing children
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startAug 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiza Junqueira Ferrer, University of Campinas, Brazil
- Investigators
- Eulalia Sakano, PhD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437877
- Sponsor's protocol ID
- LFerrer
- Status last verified
- May 2015
- First submitted
- 20 Mar 2011
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hitos SF, Arakaki R, Sole D, Weckx LL. Oral breathing and speech disorders in children. J Pediatr (Rio J). 2013 Jul-Aug;89(4):361-5. doi: 10.1016/j.jped.2012.12.007. Epub 2013 Jul 1.
PubMed 23809686Farronato G, Giannini L, Riva R, Galbiati G, Maspero C. Correlations between malocclusions and dyslalias. Eur J Paediatr Dent. 2012 Mar;13(1):13-8.
PubMed 22455522Souki BQ, Pimenta GB, Souki MQ, Franco LP, Becker HM, Pinto JA. Prevalence of malocclusion among mouth breathing children: do expectations meet reality? Int J Pediatr Otorhinolaryngol. 2009 May;73(5):767-73. doi: 10.1016/j.ijporl.2009.02.006. Epub 2009 Mar 12.
PubMed 19282036Ziliotto KN, dos Santos MF, Monteiro VG, Pradella-Hallinan M, Moreira GA, Pereira LD, Weckx LL, Fujita RR, Pizarro GU. Auditory processing assessment in children with obstructive sleep apnea syndrome. Braz J Otorhinolaryngol. 2006 May-Jun;72(3):321-7. doi: 10.1016/s1808-8694(15)30963-0.
PubMed 17119766Ersu R, Arman AR, Save D, Karadag B, Karakoc F, Berkem M, Dagli E. Prevalence of snoring and symptoms of sleep-disordered breathing in primary school children in istanbul. Chest. 2004 Jul;126(1):19-24. doi: 10.1378/chest.126.1.19.
PubMed 15249437Lamberg L. Sleep-disordered breathing may spur behavioral, learning problems in children. JAMA. 2007 Jun 27;297(24):2681-3. doi: 10.1001/jama.297.24.2681. No abstract available.
PubMed 17595262Hamasaki Uema SF, Nagata Pignatari SS, Fujita RR, Moreira GA, Pradella-Hallinan M, Weckx L. Assessment of cognitive learning function in children with obstructive sleep breathing disorders. Braz J Otorhinolaryngol. 2007 May-Jun;73(3):315-20. doi: 10.1016/s1808-8694(15)30074-4.
PubMed 17684651
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mouth Breathing in the Discrimination of Sonority Perception in Writing
- ClinicalTrials.gov ID
- NCT02437877
- Acronym / sponsor ID
- LFerrer
- Conditions
- Mouth Breathing
- Keywords
- Respiration, Learning, Speech, Language and Hearing Sciences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 8 May 2015 (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 examine whether nasal breathing influences the perception of sound causing trade between hard and soft consonants in the writing of children in school age and the incidence of trade.
Detailed description
To achieve the above goal explained, it was used:
Methods: The sample was consisted of 200 children, 100 previously diagnosed with oronasal breath (51 females and 49 males) who participated in the study group and 100 nasal breathers (54 females and 46 males) which were the control group. 36 words were dictated as minimal pairs to be written. Then a story was submitted in sequence of six figures from which the subjects produced a text.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouth Breather | – | –Mouth Breathers Children from 7 to 13 years old |
| Nasal Breather | – | –Nasal breathers children from 7 to 13 years old |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 200 children, 100 previously diagnosed with oronasal breath (51 females and 49 males) who participated in the study group and 100 nasal breathers (54 females and 46 males) which were the control group.
Key inclusion criteria (2 listed)
- Mouth Breather/Nasal Breather
- Literate
Key exclusion criteria (2 listed)
- Hearing trouble
- Speech trouble
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
Comparison between production written and directed free nose breathers and mouth breathing children
Time frame: up to 8 weeks
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 8 May 2015.
- Results publication: PubMed 23809686Hitos SF, Arakaki R, Sole D, Weckx LL. Oral breathing and speech disorders in children. J Pediatr (Rio J). 2013 Jul-Aug;89(4):361-5. doi: 10.1016/j.jped.2012.12.007. Epub 2013 Jul 1.
- Results publication: PubMed 22455522Farronato G, Giannini L, Riva R, Galbiati G, Maspero C. Correlations between malocclusions and dyslalias. Eur J Paediatr Dent. 2012 Mar;13(1):13-8.
- Results publication: PubMed 19282036Souki BQ, Pimenta GB, Souki MQ, Franco LP, Becker HM, Pinto JA. Prevalence of malocclusion among mouth breathing children: do expectations meet reality? Int J Pediatr Otorhinolaryngol. 2009 May;73(5):767-73. doi: 10.1016/j.ijporl.2009.02.006. Epub 2009 Mar 12.
- Results publication: PubMed 17119766Ziliotto KN, dos Santos MF, Monteiro VG, Pradella-Hallinan M, Moreira GA, Pereira LD, Weckx LL, Fujita RR, Pizarro GU. Auditory processing assessment in children with obstructive sleep apnea syndrome. Braz J Otorhinolaryngol. 2006 May-Jun;72(3):321-7. doi: 10.1016/s1808-8694(15)30963-0.
- Results publication: PubMed 15249437Ersu R, Arman AR, Save D, Karadag B, Karakoc F, Berkem M, Dagli E. Prevalence of snoring and symptoms of sleep-disordered breathing in primary school children in istanbul. Chest. 2004 Jul;126(1):19-24. doi: 10.1378/chest.126.1.19.
- Results publication: PubMed 17595262Lamberg L. Sleep-disordered breathing may spur behavioral, learning problems in children. JAMA. 2007 Jun 27;297(24):2681-3. doi: 10.1001/jama.297.24.2681. No abstract available.
- Results publication: PubMed 17684651Hamasaki Uema SF, Nagata Pignatari SS, Fujita RR, Moreira GA, Pradella-Hallinan M, Weckx L. Assessment of cognitive learning function in children with obstructive sleep breathing disorders. Braz J Otorhinolaryngol. 2007 May-Jun;73(3):315-20. doi: 10.1016/s1808-8694(15)30074-4.
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.
Eulalia Sakano, PhD principal investigator
University of Campinas, Brazil
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 University of Campinas, Brazil 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 2 inclusion and 2 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 8 May 2015. 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?
Comparison between production written and directed free nose breathers and mouth breathing children (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02437877, which also lists 7 linked publications.
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 8 May 2015.