Aspects Associated With Sleep Quality

March 14, 2022 updated by: Noéli Boscato, PhD, Federal University of Pelotas

Aspects Associated With Bruxism and 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).

Study Overview

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • RS
      • Pelotas, RS, Brazil, 96015-560
        • Noéli Boscato
    • Rio Grande Do Sul
      • Pelotas, Rio Grande Do Sul, Brazil, 96015560
        • Noéli Boscato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adults (aged 20 to 60 years) and elderly (aged > 60 years) who had undergone PSG at the Pelotas Sleep Institute (ISP), a private medical out patients clinic, from January to December 2019, will be invited to participate in the study.

Eligibility criteria includ adequate cognitive capacity to understand and answer the questionnaire. Written consent will be given by all participants who agreed to participate in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals with sleep bruxism

Individuals with sleep bruxism evaluated in three different methods regarding their sleep quality:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months after study start
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%).
4 months after study start
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%).
4 months after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

January 1, 2022

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (ACTUAL)

December 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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