Aspects Associated With Bruxism and Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Data Collect on Sleep Quality with the APP
研究概览
简要总结
Evaluate the correlation among the diagnostics of sleep bruxism and sleep quality obtained from the use of smartphone application (APP-Sleep Cycle®), PSG and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson).
详细描述
This study will evaluate the correlation between sleep bruxism and sleep quality diagnoses obtained using the application of the smartphone (APP-Sleep Cycle®), polysomnography and questionnaires (Pittsburgh Sleep Quality Index-IQSP and Johansson). Subjects (n = 40) between 19 and 60 years old will be submitted to polysomnography from January to December 2019. The questionnaires will be applied before the polysomnography, and the APP will be used together with the polysomnography. The data will be tabulated and a descriptive statistical analysis performed. Specific statistical tests will be determined after preliminary analysis of the data (α = 0.05).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (aged 20 to 60 years) and elderly (aged > 60 years) (WHO-World Health Organization, 2015) who will be undergone PSG at the Pelotas Sleep Institute (ISP);
- •Adequate cognitive capacity to understand and answer the questionnaire.
排除标准
- •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.
结局指标
主要结局
Data Collect on Sleep Quality with the APP
时间窗: 4 months after study start
The sleep quality data will be collected in the APP along with the polysomnography exam, and the efficiency of the sleep is measured (god \>80% or bad \<80%).
Data Collect on Sleep Quality with ISQP quastionario.
时间窗: 4 months after study start
Sleep quality data will be collected from the ISQP quastionario
Data Collect on Sleep Quality with polysomnography exam
时间窗: 4 months after study start
The sleep quality data will be collected in the polysomnography exam along with the APP, and the efficiency of the sleep is measured (god \>80% or bad \<80%).
次要结局
未报告次要终点
研究者
Noéli Boscato, PhD
Associate Professor
Federal University of Pelotas