The Influence of Breathing in Writing | NCT02437877

Studies
The Influence of Breathing in Writing

NCT02437877

Sponsor

University of Campinas, Brazil

Status

Completed

Last Update Posted

May 8, 2015Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Mouth Breathing

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Mar 20, 2011

First Submission Date that Met QC Criteria

May 7, 2015

First Posted Date

May 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2015

Last Update Posted Date

May 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luiza Junqueira Ferrer, University of Campinas, Brazil, University of Campinas, BrazilPrincipal Investigator

Lead Sponsor

University of Campinas, BrazilOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mouth Breather		Mouth Breathers Children from 7 to 13 years old
Nasal Breather		Nasal breathers children from 7 to 13 years old

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between production written and directed free nose breathers and mouth breathing children		up to 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mouth Breather/Nasal Breather
Literate

Exclusion Criteria:

Hearing trouble
Speech trouble

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

13 Years

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eulalia Sakano, PhD	University of Campinas, Brazil	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Campinas		Campinas	São Paulo		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23809686	Result	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.
22455522	Result	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.

ID	Term
D009058	Mouth Breathing
D053120	Respiratory Aspiration
D013060	Speech
D007802	Language

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms