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

NCT04015349 | Completed

• 1 other identifier: FUPelotas5
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional study will evaluate the association between sociodemographic, occupational, clinical conditions, psychological (sense of coherence), sleep quality variables and SB diagnosed by PSG, the gold standard exam with audio-visual resources obtained at Pelotas Sleep Institute.

Conditions

Sleep Bruxism, Adult

Keywords

grind; polysomnography; rhythmic masticatory muscle activity; sleep bruxism

Outcome Measures

Primary Outcomes (1)

• Patients with Sleep Bruxism 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.

  4 months

Interventions

Polysomnography 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)

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All records obtained from adults (aged 20 to 60 years) and elderly (aged \>60 years) who had undergone PSG at a private medical outpatients clinic from July 2017 to February 2018 were reviewed.

You may qualify if:

• All adults (aged 20 to 60 years) and elderly (aged \>60 years)

You may not qualify if:

• Inadequate cognitive capacity to understand and answer the questionnaires;
• Degraded PSG image quality;
• Questionnaires filled incorrectly;
• Participants who presented a history of epilepsy that could interfere in the results of polysomnography.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96077590, Brazil

Location

MeSH Terms

Conditions

Sleep Bruxism

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Noéli Boscato, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 11, 2019
• Study Start: July 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: February 1, 2018
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

BR (1)