Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism
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ClinicalTrials.gov Identifier: NCT03825237 |
Recruitment Status :
Completed
First Posted : January 31, 2019
Last Update Posted : July 8, 2019
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Condition or disease | Intervention/treatment |
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Sleep Bruxism, Adult | Diagnostic Test: Polysomnography |
Currently, as sleep and awake bruxism are generally considered as different behaviours observed during sleep and wakefulness, respectively, the single definition for bruxism is recommended be "retired" in favour of 2 separate definitions. In this sense, the sleep bruxism is a masticatory muscle activity during sleep that is characterised as rhythmic (phasic) or non-rhythmic (tonic) and is not a movement disorder or a sleep disorder in otherwise healthy individuals .The diagnosis of sleep bruxism often is challenging and despite the use of questionnaires, clinical exams and portable devices, based on current knowledge, the polysomnography with audio-video recordings emerges as the gold-standard criteria for a definite sleep bruxism diagnosis.
Included on the questionnaire there is a registration form, which contains: Sociodemographic: self-reported ethnicity, marital status, education level; Occupational: individuals were asked about work outside home, working hours; Clinical condition: body mass index, smoking; alcohol consumption; use of sleeping pills.
Sleep Quality, was evaluated with the following questions: Sleep behavioral, how long does it take to sleep; restless sleep; nightmares; heartburn, obstructive sleep apnea by polysomnography. Bedtime, sleep time. Waking during the night, insomnia. Morning wake up, headache on waking; Lastly, Sleep structure data: sleep onset latency, rapid eye movement, sleep latency, wake time after sleep onset, total sleep time, sleep efficiency, non-rapid eye movement, sleep time in stages N1, N2, and N3, REM sleep time, arousal, arousal per hour, respiratory disturbance index, apnea-hypopnea index; and Epworth Sleepiness Scale.
Study Type : | Observational |
Actual Enrollment : | 116 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism: a Case-control Study |
Actual Study Start Date : | January 1, 2018 |
Actual Primary Completion Date : | July 24, 2018 |
Actual Study Completion Date : | November 15, 2018 |
Group/Cohort | Intervention/treatment |
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With sleep bruxism by polysomnography
Adults (20 to 60 years) and elderly (> 60 years), (WHO-World Health Organization, 2015) who had undergone polysomnography (PSG) from January 2015 to December 2017 were assessed. All self-reports and PSG exams were included and reviewed. The participants were excluded if they presented with a history of neurological or degenerative disorders, and any objection to take the polysomnography test.
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Diagnostic Test: Polysomnography
The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism) |
Without sleep bruxism by polysomnography
Adults (20 to 60 years) and elderly (> 60 years), (WHO-World Health Organization, 2015) who had undergone polysomnography (PSG) from January 2015 to December 2017 were assessed. All self-reports and PSG exams were included and reviewed. The participants were excluded if they presented with a history of neurological or degenerative disorders, and any objection to take the polysomnography test.
|
Diagnostic Test: Polysomnography
The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism) |
- Sleep Bruxism [ Time Frame: 4 months ]Patients included in the study received diagnosis of SB by polysomnography exams. The data were obtained from polysomnography records in which masseter electromyography (EMG) burst was detected based on a predefined EMG threshold (20% of maximal voluntary tooth clenching task). Right masseter EMG bursts exceeding 0.25 second in duration were selected for oromotor activity scoring according to published criteria. Oromotor episodes separated by 3-second intervals were recognized as rhythmic masticatory muscle activity (RMMA) if they corresponded to 1 of the 3 following patterns: phasic (3 or more EMG bursts, each lasting 0.25 to 2 seconds), tonic (1 EMG burst lasting more than 2 seconds), or mixed (both burst types) episodes. EMG bursts were considered within the same RMMA episode if the interval between them was shorter than 2 seconds. Participants had SB diagnosed by polysomnography (PSG) if the RMMA index was greater than 2 episodes per hour of sleep.

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Ages Eligible for Study: | 20 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adults (aged 20 to 60 years) and elderly (aged > 60 years) (WHO-World Health Organization, 2015) who were undergone to polysomnography (PSG) at the Pelotas Sleep Institute (PSI);
- Adequate cognitive capacity to understand and answer the questionnaire.
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.

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): NCT03825237
Brazil | |
Federal University of Pelotas | |
Pelotas, RS, Brazil, 96015-560 |
Principal Investigator: | Noéli Boscato, PhD | Federal University of Pelotas |
Publications:
Responsible Party: | Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas |
ClinicalTrials.gov Identifier: | NCT03825237 History of Changes |
Other Study ID Numbers: |
FUPelotas3 |
First Posted: | January 31, 2019 Key Record Dates |
Last Update Posted: | July 8, 2019 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
diagnostic polysomnography sleep architecture sleep bruxism |
Bruxism Sleep Bruxism Tooth Diseases Stomatognathic Diseases |
Parasomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders |