NCT01019525

Brief Summary

The purpose of this study is to characterize the posture and respiratory function of mouth-breathing children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

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

June 1, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 26, 2009

Status Verified

November 1, 2009

Enrollment Period

4 years

First QC Date

November 24, 2009

Last Update Submit

November 25, 2009

Conditions

Mouth Breathing

Keywords

respirationrespiratory disordersOtolaryngologyOtorhinolaryngologyPosture

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function, by means of forced spirometry.

    Within the first 30 days after recruitment.

Secondary Outcomes (1)

  • Posture, by means of photogrammetry.

    Within the first 30 days after recruitment.

Study Arms (2)

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

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Location

MeSH Terms

Conditions

Mouth BreathingRespiratory AspirationRespiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Sara LS Menezes, PhD

    Universidade Federal do Rio de Janeiro

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

June 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

BR(1)