Aspects Associated With Sleep Quality

Completed

• Conditions: Sleep Bruxism
• Interventions: Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and Johansson; Diagnostic Test: Smartphone APP; Diagnostic Test: Polysomnography

• Registration Number: NCT03766477
• Lead Sponsor: Federal University of Pelotas

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-06
• Study Start: 2019-01-01
• Primary Completion: 2021-04-01
• Study Completion: 2022-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with sleep bruxism	Smartphone APP	Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality: * Pittsburgh Sleep Quality Index (IQSP) and Johansson * Smartphone APP * Polysomnography
Individuals with sleep bruxism	Pittsburgh Sleep Quality Index (IQSP) and Johansson	Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality: * Pittsburgh Sleep Quality Index (IQSP) and Johansson * Smartphone APP * Polysomnography
Individuals with sleep bruxism	Polysomnography	Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality: * Pittsburgh Sleep Quality Index (IQSP) and Johansson * Smartphone APP * Polysomnography

Primary Outcome Measures

Name	Time	Method
Data Collect on Sleep Quality with the APP	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.	4 months after study start	Sleep quality data will be collected from the ISQP quastionario
Data Collect on Sleep Quality with polysomnography exam	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%).

Trial Locations

Locations (1)

Noéli Boscato; 🇧🇷 Pelotas, RS, Brazil