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Aspects Associated With Sleep Quality

Aspects Associated With Bruxism and Sleep Quality

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03766477
Enrollment
40
Registered
2018-12-06
Start date
2019-01-01
Completion date
2022-01-01
Last updated
2022-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Bruxism

Keywords

Sleep bruxism, Sleep, Sleep hygiene

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).

Interventions

DIAGNOSTIC_TESTPittsburgh 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.

DIAGNOSTIC_TESTSmartphone 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.

DIAGNOSTIC_TESTPolysomnography

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

Sponsors

Federal University of Pelotas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Data Collect on Sleep Quality with polysomnography exam4 months after study startThe 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%).
Data Collect on Sleep Quality with ISQP quastionario.4 months after study startSleep quality data will be collected from the ISQP quastionario
Data Collect on Sleep Quality with the APP4 months after study startThe 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%).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026