- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810248
Association Between Obstructive Sleep Apnea and Bruxism
March 14, 2022 updated by: Noéli Boscato, PhD, Federal University of Pelotas
Association Between Obstructive Sleep Apnea and Bruxism: A Retrospective Study
The objective of this retrospective observational study will be to investigate the between the Obstructive Sleep Apnea Syndrome (OSAS) and Sleep Bruxism (SB), in individuals diagnosed through polysomnography (PSG).
Study Overview
Status
Completed
Conditions
Detailed Description
The SB and OSAS are sleep disorders with great importance for dentistry.
The OSAS is characterized by partial or total obstruction of the upper airways.
SB is defined as a repetitive activity of the mandibular musculature characterized by the tightening or grinding of the teeth and/or by the retrusion or propulsion of the mandible.
This study retrospective observational will be evaluation to investigate the association between OSAS and SB.
Data from PSG and medical records (n=640) will be collected from January 2012 to July 2018 at "Instituto do Sono de Pelotas (ISP)".
Study Type
Observational
Enrollment (Actual)
640
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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RS
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Pelotas, RS, Brazil, 96015-560
- Federal University of Pelotas
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Individuals who have undergone polysomnography at the Instituto do Sono de Pelotas (ISP) between March 2012 and July 2018, who meet inclusion criteria.
Description
Inclusion Criteria:
- Adults (aged 20 to 60 years) and elderly (aged > 60 years) (WHO-World Health Organization, 2015) who was undergone PSG at the "Instituto do Sono de Pelotas (ISP)";
- Have completed all the respective PSG reports.
Exclusion Criteria:
•Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tabulation of polysomnographic report related to sleep efficiency
Time Frame: The deadline is until May 2020 to have all data collected
|
These data are provided from the medical report generated in the polysomnography examination in%.
Values above 85% will be classified as good sleep efficiency, and values below 85% will be classified as poor sleep efficiency.
These polysomnographic exams were performed at the "Sleep Institute of Pelotas (ISP)" from January 2012 to July 2018.
|
The deadline is until May 2020 to have all data collected
|
|
Tabulation of polysomnographic report related to sleep bruxism
Time Frame: The deadline is until May 2020 to have all data collected
|
These data are provided from the medical report generated in the polysomnography examination in the presence or absence of sleep bruxism.
These polysomnographic exams were performed at the "Sleep Institute of Pelotas (ISP)" from January 2012 to July 2018.
|
The deadline is until May 2020 to have all data collected
|
|
Tabulation of polysomnographic report related to obstructive sleep apnea syndrome (SAOS)
Time Frame: The deadline is until May 2020 to have all data collected
|
OSAS is classified according to its severity, which varies according to the number of apnea and hypopnea indexes per hour (AHI), 15; moderate of 16-30, and recorded the first upper 31 episodes.
These data are provided from the medical report generated in the polysomnography.
These polysomnographic exams were performed at the "Sleep Institute of Pelotas (ISP)" from January 2012 to July 2018.
|
The deadline is until May 2020 to have all data collected
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2019
Primary Completion (Actual)
September 1, 2021
Study Completion (Actual)
February 1, 2022
Study Registration Dates
First Submitted
November 6, 2018
First Submitted That Met QC Criteria
January 16, 2019
First Posted (Actual)
January 18, 2019
Study Record Updates
Last Update Posted (Actual)
March 16, 2022
Last Update Submitted That Met QC Criteria
March 14, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Stomatognathic Diseases
- Parasomnias
- Signs and Symptoms, Respiratory
- Tooth Diseases
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Bruxism
- Sleep Bruxism
Other Study ID Numbers
- FUPelotas 4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.