Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism
Status:
Completed
Sponsors
Federal University of Pelotas
Abstract:
This case-control study will evaluates the association between the definitive sleep bruxism diagnosis by gold-standard polysomnography examination obtained at Pelotas Sleep Institute and the sociodemographic, occupational, clinical conditions, sleep quality, sleep structure and Epworth sleepiness scale variables.
Description:
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.
Last Verified:May/31/2019
First Submitted:November/18/2018
Estimated Enrollment Submitted:January/29/2019
First Posted:January/30/2019
Last Update Submitted:July/3/2019
Last Update Posted:July/7/2019
Actual Study Start Date:December/31/2017
Estimated Primary Completion Date:July/23/2018
Estimated Study Completion Date:November/14/2018
Condition or disease:Sleep Bruxism, Adult
Intervention/treatment:
Diagnostic Test:
Phase:-
Study design:
Study Type:Observational
Observational Model:Case-Control
Time Perspective:Cross-Sectional
Arm group:
ArmIntervention/treatment
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.
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.
Eligibility Criteria:
Ages Eligible for Study:20 Years to 20 Years
Sexes Eligible for Study:All
Sampling method:Non-Probability Sample
Accepts Healthy Volunteers:Yes
Criteria:

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.

Outcome:
Primary Outcome Measures
1. Sleep Bruxism [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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