Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

Study Overview
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Brief Summary
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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
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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).

Official Title
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Observational Study on Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

Conditions
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Bruxism, Temporomandibular Joint Disorders, Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Diagnostic Test: Evaluation of TMD and pain sensitivity
* Diagnostic Test: Evaluation of SB
* Diagnostic Test: Evaluation of AB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with sleep bruxism, apnea and DTM<br>Patients who will undergo analysis of: Evaluation of TMD and pain sensitivity Evaluation of SB Evaluation of AB | Diagnostic Test: Evaluation of TMD and pain sensitivity<br>* Extra and intraoral clinical examination will be performed and the Diagnostic Criteria for Temporomandibular Disorders (DC / TMD) questionnaire will be applied. Measurements shall be bilateral in the masseter, anterior temporal and tenar muscles and the arithmetic mean between three measurements will be considered the value for each side for pain sensitivity analysis with an dynamometer.<br>Diagnostic Test: Evaluation of SB<br>* The presence or absence of SB will be diagnosed by Polysomnography<br>Diagnostic Test: Evaluation of AB<br>* A smartphone will be used, which was developed for a momentary evaluation that allows a report of the exact moment of AB and its possible associated symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polisomnography analysis | Patients included in the study will receive polisomnography exams for diagnosis of SB and OSAS. The data will be obtained from polisomnography records | 4 months after study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TMD assessment | All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams. | 6 months after study start | 
| Diagnosis of awake bruxism | All patients will use a Smartphone application after undergone polisomnography | 8 months after study start | 
| TMD pain | All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer. | 10 months after study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep bruxism, polisomnography, sleep wake disorders