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临床试验/NCT04015349
NCT04015349已完成不适用

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

Federal University of Pelotas1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
试验地点
1
主要终点
Patients with Sleep Bruxism by Polysomnography exams

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Patients with Sleep Bruxism by Polysomnography exams

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Federal University of Pelotas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Noéli Boscato, PhD

Associate Professor

Federal University of Pelotas

研究点 (1)

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