Aspects Associated With Sleep Quality

Sleep Bruxism Clinical Trial

Official title:

Aspects Associated With Bruxism and Sleep Quality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766477
• Other study ID #: FUPelotas2
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2022
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Sleep Bruxism

Intervention

Diagnostic Test:
• Pittsburgh Sleep Quality Index (IQSP) and Johansson
All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.
• Smartphone APP
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.
• Polysomnography
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

Locations

Country	Name	City	State
Brazil	Noéli Boscato	Pelotas	Rio Grande Do Sul
Brazil	Noéli Boscato	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Collect on Sleep Quality with ISQP quastionario.	Sleep quality data will be collected from the ISQP quastionario	4 months after study start
Primary	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
Primary	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