Sleep Disorder and Oral Habits in Children (SOHab)
|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.|
|ClinicalTrials.gov Identifier: NCT01463839|
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : November 2, 2011
|Condition or disease|
|Sleep Disorder Malocclusion|
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 Type :||Observational|
|Actual Enrollment :||50 participants|
|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|
Children 3 to 6
Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo
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
|Nove de Julho University|
|Sao Paulo, Brazil, 18130 430|
|Principal Investigator:||Lara Motta, PhD||Nove de Julho University|