Clinical trial NCT03766464: Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain
Official title: Observational Study on Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bruxism
Temporomandibular Joint Disorders
Obstructive Sleep Apnea Syndrome
Keywords: sleep bruxism
polisomnography
sleep wake disorders
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults (aged 20 to 60 years) and elderly (aged \> 60 years) who had undergone PSG at the Pelotas Sleep Institute (ISP), a private medical outpatients clinic, from January to December 2019, will be invited to participate in the study. Written consent was given by all participants who agreed to participate in the study.

Brief summary: This study evaluated the influence of the sleep bruxism (SB), awake bruxism (AB) and obstructive sleep apnea syndrome (OSAS) on the signs and symptoms of temporomandibular disorders (TMD).

Detailed description: Obstructive sleep apnea (OSA) is characterized by partial or total obstruction of the upper airways. Bruxism is defined as a repetitive activity of the mandibular musculature characterized by the tightening or grinding of the teeth and/or by the retrusion or propulsion of the mandible, and according to their manifestation circadian is defined as sleep bruxism (SB) or wake bruxism (AB). This prospective clinical study will be performed with adults (20 to 60 years) and elderly (\> 60 years) (WHO-World Health Organization) who will be undergone polysomnography (PSG) at a private medical outpatients clinic from January to December 2019 to evaluate the influence of SB, AB, and OSA on signs and symptoms of TMD. The individuals will be assessed clinically and diagnosed for TMD using the "Diagnostic Criteria for Temporomandibular Disorders", for SB and OSA using PSG, and AB using the smartphone application. Specific statistical tests will be determined after preliminary analysis of the data (α= 0.05).

Eligibility criteria: Inclusion Criteria:

* Adults (aged 20 to 60 years) and elderly (aged \> 60 years) (WHO-World Health Organization, 2015) who will be undergone PSG at the Pelotas Sleep Institute (ISP);
* Adequate cognitive capacity to understand and answer the questionnaire.

Exclusion Criteria:

• Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.

Primary outcomes:
measure: Polisomnography analysis
timeFrame: 4 months after study start
Secondary outcomes:
measure: TMD assessment
timeFrame: 6 months after study start
measure: Diagnosis of awake bruxism
timeFrame: 8 months after study start
measure: TMD pain
timeFrame: 10 months after study start
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Noéli Boscato
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Noéli Boscato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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