Sleep DisorderSOHabNCT01463839
Sleep Disorder and Oral Habits in Children
An observational study of Sleep Disorder and Malocclusion, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Malocclusion
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo
Who may be able to join
- 3 to 6 years of age
Who cannot join
- over 6 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Quality of Sleep and Harmful Oral Habits Among Children
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.
Read the 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.
- Conditions
- Sleep Disorder, Malocclusion
- Keywords
- sleep disorder, malocclusion, children
- Medical subject headings
- Sleep Wake Disorders, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children 3 to 6 | Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Jansiski Motta, University of Nove de Julho
- Investigators
- Lara Motta, PhD, Principal investigator, Nove de Julho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463839
- Sponsor's protocol ID
- hab026/2010
- Acronym
- SOHab
- Status last verified
- Oct 2011
- First submitted
- 28 Oct 2011
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Quality of Sleep and Harmful Oral Habits Among Children
- ClinicalTrials.gov ID
- NCT01463839
- Acronym / sponsor ID
- SOHab / hab026/2010
- Conditions
- Sleep Disorder, Malocclusion
- Keywords
- sleep disorder, malocclusion, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children 3 to 6 | – | –Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Fifty children (3 to 6 years of age) from a private school in the city of Sao Paulo
Key inclusion criteria (1 listed)
- 3 to 6 years of age
Key exclusion criteria (1 listed)
- over 6 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Motta, PhD principal investigator
Nove de Julho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and Malocclusion, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011; AzTrials last refreshed its copy on 7 Nov 2026.