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Sleep Disorder and Oral Habits in Children (SOHab)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463839
First Posted: November 2, 2011
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lara Jansiski Motta, University of Nove de Julho
  Purpose
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
Sleep Disorder Malocclusion

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Association Between Quality of Sleep and Harmful Oral Habits Among Children

Resource links provided by NLM:


Further study details as provided by Lara Jansiski Motta, University of Nove de Julho:

Enrollment: 50
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children 3 to 6
Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo

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.

  Eligibility

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 Submitted: October 28, 2011
First Posted: November 2, 2011
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