Sleep Bruxism, Adult Clinical Trial
Official title:
Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults: a Study Using Polysomnography.
NCT number | NCT04015349 |
Other study ID # | FUPelotas5 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | February 1, 2018 |
Verified date | July 2019 |
Source | Federal University of Pelotas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | February 1, 2018 |
Est. primary completion date | November 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility |
Inclusion Criteria: - All adults (aged 20 to 60 years) and elderly (aged >60 years) Exclusion Criteria: - Inadequate cognitive capacity to understand and answer the questionnaires; - Degraded PSG image quality; - Questionnaires filled incorrectly; - Participants who presented a history of epilepsy that could interfere in the results of polysomnography. |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Pelotas | Pelotas | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Pelotas |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients with Sleep Bruxism by Polysomnography exams | The data were obtained from polysomnography records in which masseter electromyography (EMG) burst was detected based on a predefined EMG threshold (20% of maximal voluntary tooth clenching task). Right masseter EMG bursts exceeding 0.25 second in duration were selected for oromotor activity scoring according to published criteria. Oromotor episodes separated by 3-second intervals were recognized as rhythmic masticatory muscle activity (RMMA) if they corresponded to 1 of the 3 following patterns: phasic (3 or more EMG bursts, each lasting 0.25 to 2 seconds), tonic (1 EMG burst lasting more than 2 seconds), or mixed (both burst types) episodes. EMG bursts were considered within the same RMMA episode if the interval between them was shorter than 2 seconds. Participants had SB diagnosed by polysomnography (PSG) if the RMMA index was greater than 2 episodes per hour of sleep. | 4 months |
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---|---|---|---|
Not yet recruiting |
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