Sleep Disorder and Oral Habits in Children | NCT01463839

Studies
Sleep Disorder and Oral Habits in Children

NCT01463839

Sponsor

University of Nove de Julho

Status

Completed

Last Update Posted

Nov 2, 2011Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Sleep Disorder
Malocclusion

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

Oct 2011

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

Sep 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Jun 2011Actual

First Submitted Date

Oct 28, 2011

First Submission Date that Met QC Criteria

Nov 1, 2011

First Posted Date

Nov 2, 2011Estimated

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 1, 2011

Last Update Posted Date

Nov 2, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lara Jansiski Motta, PhD, University of Nove de JulhoPrincipal Investigator

Lead Sponsor

University of Nove de JulhoOTHER

Collaborators

Not provided

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

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.

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.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children 3 to 6		Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

3 to 6 years of age

Exclusion Criteria:

over 6 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lara Motta, PhD	Nove de Julho University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nove de Julho University		São Paulo	São Paulo	18130 430	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D012893	Sleep Wake Disorders
D008310	Malocclusion

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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