Clinical Trials Directory

Trials / Completed

CompletedNCT04015349

Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults.

Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults: a Study Using Polysomnography.

Status
Completed
Phase
Study type
Observational
Enrollment
240 (actual)
Sponsor
Federal University of Pelotas · Academic / Other
Sex
All
Age
20 Years – 90 Years
Healthy volunteers
Accepted

Summary

This cross-sectional study will evaluate the association between sociodemographic, occupational, clinical conditions, psychological (sense of coherence), sleep quality variables and SB diagnosed by PSG, the gold standard exam with audio-visual resources obtained at Pelotas Sleep Institute.

Detailed description

Sleep bruxism is defined as a masticatory muscle activity during sleep that is characterised as rhythmic (phasic) or non-rhythmic (tonic) and should be considered a risk factor rather than a disorder in otherwise healthy individuals. The diagnosis of sleep bruxism often is challenging and despite the use of questionnaires, clinical exams and portable devices, based on current knowledge, the polysomnography with audio-video recordings emerges as the gold-standard criteria for a definite sleep bruxism diagnosis. Included on the questionnaire there is a registration form, which contains: included: age at time of data collection , gender, marital status , and education level ; Occupational: individuals were asked about work outside home, and working hours; Clinical condition: body mass index, smoking; alcohol consumption; use of sleeping pills; respiratory allergy and Psychological: sense of coherence .

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPolysomnographyThe polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism)

Timeline

Start date
2017-07-01
Primary completion
2017-11-01
Completion
2018-02-01
First posted
2019-07-11
Last updated
2019-07-17

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04015349. Inclusion in this directory is not an endorsement.