Skip to main content
OpenTrials
Completed

NCT Number: NCT03766477

Aspects Associated With Sleep Quality

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Bruxism Behavior Bruxism Health Behavior Mental Disorders Nervous System Diseases Parasomnias Sleep Hygiene Sleep Wake Disorders Stomatognathic Diseases Tooth Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Noéli Boscato, Pelotas, Rio Grande do Sul, Brazil

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pittsburgh Sleep Quality Index (IQSP) and Johansson

Diagnostic Test

All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.

Smartphone APP

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

  1. Data Collect on Sleep Quality with ISQP quastionario.

    Time frame: 4 months after study start

    Sleep quality data will be collected from the ISQP quastionario

  2. Data Collect on Sleep Quality with the APP

    Time frame: 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%).

  3. Data Collect on Sleep Quality with polysomnography exam

    Time frame: 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%).

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

Aspects Associated With Bruxism and Sleep Quality

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 6, 2018
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.