NCT02437877

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2011

Completed
4.1 years until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

March 20, 2011

Last Update Submit

May 7, 2015

Conditions

Mouth Breathing

Keywords

RespirationLearningSpeechLanguage and Hearing Sciences

Outcome Measures

Primary Outcomes (1)

  • Comparison between production written and directed free nose breathers and mouth breathing children

    up to 8 weeks

Study Arms (2)

Mouth Breather

Mouth Breathers Children from 7 to 13 years old

Nasal Breather

Nasal breathers children from 7 to 13 years old

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Mouth Breather/Nasal Breather
  • Literate

You may not qualify if:

  • Hearing trouble
  • Speech trouble

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas

Campinas, São Paulo, Brazil

Location

Related Publications (7)

  • 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.

    PMID: 23809686RESULT

  • Farronato G, Giannini L, Riva R, Galbiati G, Maspero C. Correlations between malocclusions and dyslalias. Eur J Paediatr Dent. 2012 Mar;13(1):13-8.

    PMID: 22455522RESULT

  • Souki 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.

    PMID: 19282036RESULT

  • Ziliotto 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.

    PMID: 17119766RESULT

  • Ersu 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.

    PMID: 15249437RESULT

  • Lamberg 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.

    PMID: 17595262RESULT

  • Hamasaki 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.

    PMID: 17684651RESULT

MeSH Terms

Conditions

Mouth BreathingRespiratory AspirationSpeechLanguage

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesVerbal BehaviorCommunicationBehavior

Study Officials

  • Eulalia Sakano, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University of Campinas, Brazil

Study Record Dates

First Submitted

March 20, 2011

First Posted

May 8, 2015

Study Start

August 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

BR(1)