Aspects Associated With Sleep Quality

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Aspects Associated With Bruxism and Sleep Quality

Conditions
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Sleep Bruxism

Intervention / Treatment
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* Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and Johansson
* Diagnostic Test: Smartphone APP
* Diagnostic Test: Polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with sleep bruxism<br>Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality: Pittsburgh Sleep Quality Index (IQSP) and Johansson Smartphone APP Polysomnography | Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and Johansson<br>* All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.<br>Diagnostic Test: Smartphone APP<br>* All study participants will use a smartphone application (APP), which will be made available by the researchers, at the same time as the polysomnography exam.<br>Diagnostic Test: Polysomnography<br>* All participants slept for one night in a sleep laboratory for PSG recording. The data will be confirmed by an otorhinolaryngology certified by the Brazilian Association of Sleep Disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collect on Sleep Quality with ISQP quastionario. | Sleep quality data will be collected from the ISQP quastionario | 4 months after study start | 
| Data Collect on Sleep Quality with the APP | 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%). | 4 months after study start | 
| Data Collect on Sleep Quality with polysomnography exam | 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%). | 4 months after study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep bruxism, Sleep, Sleep hygiene