Sleep BruxismNCT03766477
Aspects Associated With Sleep Quality
An observational study of Sleep Bruxism, run by Federal University of Pelotas at 2 sites in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism
- What is being tested?
- Pittsburgh Sleep Quality Index (IQSP) and Johansson, Smartphone APP and Polysomnography
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Jan 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Noéli Boscato
Pelotas, Rio Grande do Sul, 96015-560
Noéli Boscato
Pelotas, Rio Grande do Sul, 96015560
About this study
Official title: 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).
Read the 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
- Sleep Bruxism
- Being tested
- Pittsburgh Sleep Quality Index (IQSP) and Johansson, Smartphone APP, Polysomnography
- Keywords
- Sleep bruxism, Sleep, Sleep hygiene
- Medical subject headings
- Sleep Bruxism, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pittsburgh Sleep Quality Index (IQSP) and JohanssonDiagnostic test
All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.
Smartphone APPDiagnostic 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.
PolysomnographyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and Johansson; Diagnostic Test: Smartphone APP; Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collect on Sleep Quality with ISQP quastionario.
Sleep quality data will be collected from the ISQP quastionario
Measured: 4 months after study start
Data Collect on Sleep Quality with the APP
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%).
Measured: 4 months after study start
Data Collect on Sleep Quality with polysomnography exam
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%).
Measured: 4 months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Jan 2019
- Primary completion1 Apr 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noéli Boscato, PhD, Federal University of Pelotas
- Investigators
- Noéli Boscato, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766477
- Sponsor's protocol ID
- FUPelotas2
- Status last verified
- Mar 2022
- First submitted
- 6 Nov 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspects Associated With Bruxism and Sleep Quality
- ClinicalTrials.gov ID
- NCT03766477
- Acronym / sponsor ID
- FUPelotas2
- Conditions
- Sleep Bruxism
- Keywords
- Sleep bruxism, Sleep, Sleep hygiene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with sleep bruxism | – | Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and Johansson, Diagnostic Test: Smartphone APP, Diagnostic Test: PolysomnographyIndividuals with sleep bruxism evaluated in three different methods regarding their sleep quality: * Pittsburgh Sleep Quality Index (IQSP) and Johansson * Smartphone APP * Polysomnography |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pittsburgh 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 test | Individuals with sleep bruxism |
| Smartphone 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 test | Individuals with sleep bruxism |
| PolysomnographyAll 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 | Diagnostic test | Individuals with sleep bruxism |
Primary outcome
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
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%).
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%).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noéli Boscato, PhD principal investigator
Federal University of Pelotas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Bruxism, run by Federal University of Pelotas at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collect on Sleep Quality with ISQP quastionario. (time frame: 4 months after study start). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.