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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Polysomnography | The 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.