Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain

• ClinicalTrials.gov Identifier: NCT03766464
• Recruitment Status: Active, not recruiting
• First Posted: December 6, 2018
• Last Update Posted: February 2, 2021
• Sponsor: Federal University of Pelotas
• Information provided by (Responsible Party): Noéli Boscato, PhD, Federal University of Pelotas

Study Description

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).

Condition or disease	Intervention/treatment
Bruxism; Temporomandibular Joint Disorders; Obstructive Sleep Apnea Syndrome	Diagnostic Test: Evaluation of TMD and pain sensitivity; Diagnostic Test: Evaluation of SB; Diagnostic Test: Evaluation of AB

Detailed Description:

The OSAS 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. This prospective clinical study will be performed with adults (20 to 60 years) and elderly (> 60 years) (WHO-World Health Organization) who will be had undergone PSG at the ISP , a private medical outpatients clinic from January to December 2019 to evaluate the influence of SB, AB and OSAS 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 OSAS using PSG, and AB using the smartphone application. Specific statistical tests will be determined after preliminary analysis of the data (α= 0.05).

Study Design

• Study Type: Observational
• Estimated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Observational Study on Aspects Associated With Obstructive Sleep Apnea, Bruxism and Orofacial Pain
• Actual Study Start Date: January 1, 2019
• Estimated Primary Completion Date: June 1, 2021
• Estimated Study Completion Date: July 1, 2022

Groups and Cohorts

Group/Cohort

Intervention/treatment

with sleep bruxism, apnea and DTM; 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; 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.; Diagnostic Test: Evaluation of SB; The presence or absence of SB will be diagnosed by Polysomnography; Diagnostic Test: Evaluation of AB; 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.

Outcome Measures

Primary Outcome Measures :

1. Polisomnography analysis [ Time Frame: 4 months after study start ]
   Patients included in the study will receive polisomnography exams for diagnosis of SB and OSAS. The data will be obtained from polisomnography records

Secondary Outcome Measures :

1. TMD assessment [ Time Frame: 6 months after study start ]
   All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams.
2. Diagnosis of awake bruxism [ Time Frame: 8 months after study start ]
   All patients will use a Smartphone application after undergone polisomnography
3. pain sensitivity [ Time Frame: 10 months after study start ]
   All patients who had undergone polisomnography will answer the DC / TMD questionaire and clinical exams with algometer.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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.

Contacts and Locations

Locations

Brazil

Noéli Boscato

Pelotas, RS, Brazil, 96015-560

Sponsors and Collaborators

Federal University of Pelotas

Investigators

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

More Information

• Responsible Party: Noéli Boscato, PhD, Associate Professor, Federal University of Pelotas
• ClinicalTrials.gov Identifier: NCT03766464
• Other Study ID Numbers: FUPelotas1
• First Posted: December 6, 2018
• Last Update Posted: February 2, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

sleep bruxism; polisomnography; sleep wake disorders

Additional relevant MeSH terms:

Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Bruxism; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Facial Pain; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Tooth Diseases; Stomatognathic Diseases; Musculoskeletal Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Muscular Diseases; Myofascial Pain Syndromes; Pain; Neurologic Manifestations