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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04015349
Recruitment Status : Completed
First Posted : July 11, 2019
Last Update Posted : July 17, 2019
Information provided by (Responsible Party):
Noéli Boscato, PhD, Federal University of Pelotas

Brief 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.

Condition or disease Intervention/treatment
Sleep Bruxism, Adult Diagnostic Test: Polysomnography

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 .

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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults: a Study Using Polysomnography.
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : February 1, 2018

Intervention Details:
  • 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)

Primary Outcome Measures :
  1. Patients with Sleep Bruxism by Polysomnography exams [ Time Frame: 4 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All records obtained from adults (aged 20 to 60 years) and elderly (aged >60 years) who had undergone PSG at a private medical outpatients clinic from July 2017 to February 2018 were reviewed.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04015349

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Federal University of Pelotas
Pelotas, RS, Brazil, 96077590
Sponsors and Collaborators
Federal University of Pelotas
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Principal Investigator: Noéli Boscato, PhD Federal University of Pelotas

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Responsible Party: Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas Identifier: NCT04015349     History of Changes
Other Study ID Numbers: FUPelotas5
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noéli Boscato, PhD, Federal University of Pelotas:
rhythmic masticatory muscle activity
sleep bruxism
Additional relevant MeSH terms:
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Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders