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

Sleep Bruxism, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015349
• Other study ID #: FUPelotas5
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: July 2019
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Bruxism
• Sleep Bruxism
• Sleep Bruxism, Adult

Intervention

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)

Locations

Country	Name	City	State
Brazil	Federal University of Pelotas	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

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