Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Association Between Obstructive Sleep Apnea and Bruxism

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03810248
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Noéli Boscato, PhD, Federal University of Pelotas

Brief Summary:
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).

Condition or disease
Bruxism, Sleep Obstructive Sleep Apnea

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)".

Layout table for study information
Study Type : Observational
Estimated Enrollment : 640 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between Obstructive Sleep Apnea and Bruxism: A Retrospective Study
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.


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): NCT03810248


Contacts
Layout table for location contacts
Contact: Noéli Boscato, PhD +55 53999530000 noeliboscato@gmail.com

Locations
Layout table for location information
Brazil
Federal University of Pelotas Recruiting
Pelotas, RS, Brazil, 96015-560
Contact: Noéli Boscato, PhD    55533260-2801    noeliboscato@gmail.com   
Sponsors and Collaborators
Federal University of Pelotas
Investigators
Layout table for investigator information
Principal Investigator: Noéli Boscato, PhD Federal University of Pelotas

Layout table for additonal information
Responsible Party: Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT03810248     History of Changes
Other Study ID Numbers: FUPelotas 4
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noéli Boscato, PhD, Federal University of Pelotas:
sleep bruxism
polisomnography
Additional relevant MeSH terms:
Layout table for MeSH terms
Bruxism
Sleep Bruxism
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Mental Disorders