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Clinical Trials/NCT04015349
NCT04015349
Completed
Not Applicable

Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults: a Study Using Polysomnography.

Federal University of Pelotas1 site in 1 country240 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Bruxism, Adult
Sponsor
Federal University of Pelotas
Enrollment
240
Locations
1
Primary Endpoint
Patients with Sleep Bruxism by Polysomnography exams
Status
Completed
Last Updated
6 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
February 1, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Federal University of Pelotas
Responsible Party
Principal Investigator
Principal Investigator

Noéli Boscato, PhD

Associate Professor

Federal University of Pelotas

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Patients with Sleep Bruxism by Polysomnography exams

Time Frame: 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.

Study Sites (1)

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