Posture and Pulmonary Function of Mouth-breathing Children | NCT01019525

Studies
Posture and Pulmonary Function of Mouth-breathing Children

NCT01019525

Sponsor

Universidade Federal do Rio de Janeiro

Status

Completed

Last Update Posted

Nov 26, 2009Estimated

Enrollment

34Actual

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

Nov 2009

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

Jun 2004

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Nov 24, 2009

First Submission Date that Met QC Criteria

Nov 24, 2009

First Posted Date

Nov 25, 2009Estimated

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

Nov 25, 2009

Last Update Posted Date

Nov 26, 2009Estimated

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

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.

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

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulmonary function, by means of forced spirometry.		Within the first 30 days after recruitment.

Secondary Outcomes

Measure	Description	Time Frame
Posture, by means of photogrammetry.		Within the first 30 days after recruitment.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nasal breathing (normal subjects group) or mouth breathing (mouth-breathing group), and the age between eight (08) and twelve (12) for both groups.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sara LS Menezes, PhD	Universidade Federal do Rio de Janeiro	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Rio de Janeiro		Rio de Janeiro	Rio de Janeiro		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D009058	Mouth Breathing
D053120	Respiratory Aspiration
D012120	Respiration Disorders

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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