NCT03766477

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

November 6, 2018

Last Update Submit

March 14, 2022

Conditions

Sleep Bruxism

Keywords

Sleep bruxismSleepSleep hygiene

Outcome Measures

Primary Outcomes (3)

  • Data Collect on Sleep Quality with ISQP quastionario.

    Sleep quality data will be collected from the ISQP quastionario

    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%).

    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%).

    4 months after study start

Study Arms (1)

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

Diagnostic Test: Pittsburgh Sleep Quality Index (IQSP) and JohanssonDiagnostic Test: Smartphone APPDiagnostic Test: Polysomnography

Interventions

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.

Individuals with sleep bruxism
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.

Individuals with sleep bruxism
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

Individuals with sleep bruxism

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Noéli Boscato

Pelotas, Rio Grande do Sul, 96015-560, Brazil

Location

Noéli Boscato

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

MeSH Terms

Conditions

Sleep BruxismSleep Hygiene

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Noéli Boscato, PhD

    Federal University of Pelotas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 6, 2018

First Posted

December 6, 2018

Study Start

January 1, 2019

Primary Completion

April 1, 2021

Study Completion

January 1, 2022

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

BR(2)