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

Sponsor
Federal University of Pelotas (Other)
Overall Status
Completed
CT.gov ID
NCT04015349
Collaborator
(none)
240
1
7.1
34

Study Details

Study Description

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 Phase
  • 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 .

Study Design

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 :
Jul 1, 2017
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Feb 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Patients with Sleep Bruxism by Polysomnography exams [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federal University of Pelotas Pelotas RS Brazil 96077590

Sponsors and Collaborators

  • Federal University of Pelotas

Investigators

  • Principal Investigator: Noéli Boscato, PhD, Federal University of Pelotas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT04015349
Other Study ID Numbers:
  • FUPelotas5
First Posted:
Jul 11, 2019
Last Update Posted:
Jul 17, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2019