Sleep Disorder and Oral Habits in Children (SOHab)

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ClinicalTrials.gov Identifier: NCT01463839

Recruitment Status : Completed

First Posted : November 2, 2011

Last Update Posted : November 2, 2011

Sponsor:

Information provided by (Responsible Party):

Lara Jansiski Motta, University of Nove de Julho

Study Description

Brief Summary:

Sleep is a vital physiological function for the maintenance of health and quality of life. Harmful, non-nutritive and parafunctional oral habits are believed to have a negative effect on adequate rest at night. The aim of the present study was to determine associations between quality of sleep and harmful oral habits among children aged three to six years. Fifty children from a private school in São Paulo (Brazil) were evaluated using two questionnaires on sleep quality and harmful oral habits. The data were submitted to descriptive analysis. The chi-square test was employed for the categorical variables and analysis of variance (ANOVA) was carried out to compare mean values. The Student's t-test was used for all analyses, with the significance level set at 5%. The SPSS 12.0 program for Windows was used to analyze the results.

Condition or disease
Sleep Disorder Malocclusion

Detailed Description:

An observational cross-sectional study was carried out with the aim of determining associations between quality of sleep and harmful oral habits among children aged three to six years. This study was conducted in compliance with the Brazilian National Health Council/Ministry of Health guidelines contained in Resolution 196/96 and received approval from the Human Research Ethics Committee of the Universidade Metropolitana de Santos (Brazil) under process number 026/2010. Parents/guardians of all participants were properly informed regarding the objectives of the study and signed a statement of informed consent.

Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo were evaluated by means of two questionnaires administered to parents/guardians: The "Undesirable Habits Questionnaire", composed of 15 investigative questions on harmful oral habits as well as dietary and psychological factors, and the Sleep Habits Questionnaire.6 The data were submitted to descriptive analysis. The chi-square test was employed for the categorical variables and analysis of variance (ANOVA) was carried out to compare mean values. The Student's t-test was used for all analyses, with the significance level set at 5%. The SPSS 12.0 program for Windows was used to analyze the results.

Study Design


Study Type :	Observational
Actual Enrollment :	50 participants
Time Perspective:	Cross-Sectional
Official Title:	Association Between Quality of Sleep and Harmful Oral Habits Among Children
Study Start Date :	September 2010
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Children 3 to 6 Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	3 Years to 6 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo

Criteria

Inclusion Criteria:

3 to 6 years of age

Exclusion Criteria:

over 6 years of age

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463839

Locations


Brazil
Nove de Julho University
Sao Paulo, Brazil, 18130 430

Sponsors and Collaborators

University of Nove de Julho

Investigators


Principal Investigator:	Lara Motta, PhD	Nove de Julho University

More Information


Responsible Party:	Lara Jansiski Motta, PhD, University of Nove de Julho
ClinicalTrials.gov Identifier:	NCT01463839 History of Changes
Other Study ID Numbers:	hab026/2010
First Posted:	November 2, 2011 Key Record Dates
Last Update Posted:	November 2, 2011
Last Verified:	October 2011

Keywords provided by Lara Jansiski Motta, University of Nove de Julho:


sleep disorder malocclusion children

Additional relevant MeSH terms:


Sleep Wake Disorders Parasomnias Malocclusion Nervous System Diseases Neurologic Manifestations	Signs and Symptoms Mental Disorders Tooth Diseases Stomatognathic Diseases

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