Clinical Trials Directory

Trials / Completed

CompletedNCT03766477

Aspects Associated With Sleep Quality

Aspects Associated With Bruxism and Sleep Quality

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Federal University of Pelotas · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPittsburgh Sleep Quality Index (IQSP) and JohanssonAll participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.
DIAGNOSTIC_TESTSmartphone APPAll study participants will use a smartphone application (APP), which will be made available by the researchers, at the same time as the polysomnography exam.
DIAGNOSTIC_TESTPolysomnographyAll 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

Timeline

Start date
2019-01-01
Primary completion
2021-04-01
Completion
2022-01-01
First posted
2018-12-06
Last updated
2022-03-16

Locations

2 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03766477. Inclusion in this directory is not an endorsement.