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

Completed

• Conditions: Sleep Bruxism, Adult

• Registration Number: NCT04015349
• Lead Sponsor: Federal University of Pelotas

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.

Detailed Description

Sleep bruxism is defined as a masticatory muscle activity during sleep that is characterised as rhythmic (phasic) or non-rhythmic (tonic) and should be considered a risk factor rather than a 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: included: age at time of data collection , gender, marital status , and education level ; Occupational: individuals were asked about work outside home, and working hours; Clinical condition: body mass index, smoking; alcohol consumption; use of sleeping pills; respiratory allergy and Psychological: sense of coherence .

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-11-01
• Study Completion: 2018-02-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-11
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients with Sleep Bruxism by Polysomnography exams	4 months	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.

Trial Locations

Locations (1)

Federal University of Pelotas; 🇧🇷 Pelotas, RS, Brazil