- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03766477
Aspects Associated With Sleep Quality
Aspects Associated With Bruxism and Sleep Quality
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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RS
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Pelotas, RS, Brazil, 96015-560
- Noéli Boscato
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Rio Grande Do Sul
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Pelotas, Rio Grande Do Sul, Brazil, 96015560
- Noéli Boscato
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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:
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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
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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
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Sleep quality data will be collected from the ISQP quastionario
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4 months after study start
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Data Collect on Sleep Quality with the APP
Time Frame: 4 months after study start
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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%).
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4 months after study start
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Data Collect on Sleep Quality with polysomnography exam
Time Frame: 4 months after study start
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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%).
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4 months after study start
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUPelotas2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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