Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults.

NCT04015349

Sleep Bruxism, Adult

COMPLETED

Aspects Associated With Sleep Quality

NCT03766477

Sleep Bruxism

COMPLETED

Sleep Hygiene Measures for Sleep Bruxism in Children

NCT04501237

Sleep Bruxism, Childhood

UNKNOWN NA

Relationship Between Selected Parameters and Bruxism

NCT04214561

Sleep Bruxism Sleep Disorder Psychosomatic Disorder +4 more

ENROLLING_BY_INVITATION

Impact of Bruxism Related Arousals on Cardiovascular Risk in Co-morbid Insomnia and Sleep Apnea

NCT04937036

Sleep Apnea Sleep Bruxism Sleep Disorder +3 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Bruxism, Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Polysomnography

Intervention Type DIAGNOSTIC_TEST

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.

Polysomnography

Intervention Type DIAGNOSTIC_TEST

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes