Bruxism Induced by Obstructive Sleep Apnoea.

NCT07511946 | Not Yet Recruiting

• 1 other identifier: SUBK.B160.25.003
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The relationship between obstructive sleep apnea (OSA), sleep bruxism, and temporomandibular disorders is becoming clearer, but data on how upper airway volume affects bruxism due to OSA is limited. Recent studies have shown that Cone-Beam Computed Tomography (CBCT) accurately images the upper airway, enabling analysis of its volume and its potential impact on bruxism. CBCT uses low radiation doses, significantly lower than harmful levels, making it a safe method for such assessments. Understanding these relationships can inform clinical practices for managing sleep bruxism, which affects 21% of the global population. The study aims to explore how upper airway volume influences the intensity of sleep bruxism related to OSA.

Conditions

Sleep Apnea Syndrome, Obstructive; Bruxism, Sleep-Related; Upper Respiratory Tract Illness

Keywords

Sleep Apnea; Bruxism, Sleep-Related

Outcome Measures

Primary Outcomes (1)

• The relationship between obstructive sleep apnea and bruxism during sleep.

  Relationship between the three-dimensional volume of the upper airways and sleep bruxism induced by sleep apnea, determined by CBCT and polysomnography.

  01.04.2026-31.11.2026

Secondary Outcomes (8)

• Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire.

  01.04.2026-31.12.2026

• Relationship between masticatory muscle pain and anxiety assessed by Generalized Anxiety Disorder -7.

  01.04.2026-31.12.2026

• Relationship between masticatory muscle pain and perceived stress assessed by Perceived Stress Scale.

  01.04.2026-31.12.2026

• Relationship between masticatory muscle pain and satisfaction with life assessed by Satisfaction With Life Scale.

  01.04.2026-31.12.2026

• Relationship between bruxism and sleep quality assessed by Pittsburgh Sleep Quality Index - a self-report questionnaire that assesses sleep quality over a 1-month time interval.

  01.04.2026-31.12.2026

Study Arms (2)

Study Group

The study group will consist of patients with sleep bruxism and obstructive sleep apnoea. Participants will be examined based on the standardised international protocol Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Study participants will complete the following validated questionnaires assessing their psycho-emotional state and selected aspects related to the function of the stomatognathic system, including PHQ-9, PSS-10, GAD-7, SWLS, SSS-8, MIDAS, JFLS-8, TMD Pain Screener and DC/TMD Symptom Questionnaire (Diagnostic Criteria for Temporomandibular Disorders Symptom Questionnaire). In addition, the following validated sleep questionnaires will be used: EPWORTH ,PSQI and STOP-Bang Questionnaire. Subsequently, CBCT computed tomography will be performed along with polysomnography to determine the parameters of upper airway volume and sleep apnea.

Diagnostic Test: Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT) and Polysomnography

Control Group

The control group will consist of patients with sleep bruxism. Participants will be examined based on the standardised international protocol Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Study participants will complete the following validated questionnaires assessing their psycho-emotional state and selected aspects related to the function of the stomatognathic system, including PHQ-9, PSS-10, GAD-7, SWLS, SSS-8, MIDAS, JFLS-8, TMD Pain Screener and DC/TMD Symptom Questionnaire (Diagnostic Criteria for Temporomandibular Disorders Symptom Questionnaire). In addition, the following validated sleep questionnaires will be used: EPWORTH ,PSQI and STOP-Bang Questionnaire. Subsequently, CBCT computed tomography will be performed to determine the parameters of upper airway volume.

Diagnostic Test: Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT)

Interventions

Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT) and Polysomnography DIAGNOSTIC_TEST

Patients in the study group will undergo validated questionnaires assessing psycho-emotional well-being and selected aspects related to the functioning of the stomatognathic system, upper airway volume assessment using CBCT tomography and polysomnography.

Study Group

Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT) DIAGNOSTIC_TEST

Patients in the control group will undergo validated questionnaires assessing psycho-emotional well-being and selected aspects related to the functioning of the stomatognathic system, upper airway volume assessment using CBCT tomography.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 80 adult volunteers will be recruited for the research project, divided into two groups of 40 each, comprising both sexes, who will give their voluntary and informed consent to participate in the study. The study group will consist of patients with sleep bruxism and obstructive sleep apnoea. The control group will consist of patients with sleep bruxism without obstructive sleep apnoea. Participants are arbitrarily selected from a population.

You may qualify if:

• age equal to/greater than 18 years
• moderate or high risk of sleep apnea according to the STOP-Bang questionnaire
• presence of bruxism symptoms in the oral cavity according to the current international consensus on bruxism
• positive history of bruxism during sleep

You may not qualify if:

• refusal to participate in the study
• pregnancy
• breastfeeding
• presence of severe mental illness
• alcohol and/or drug addiction
• taking medications that affect the neuromuscular and/or respiratory systems
• severe systemic diseases such as cancer
• severe neurological and autoimmune diseases
• multiple missing teeth
• edentulism in the upper and/or lower jaw

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Uniwersyteckie Centrum Stomatologiczne

Wroclaw, Dolny Śląsk, 50-425, Poland

Location

Related Publications (1)

• Oksenberg A, Arons E. Sleep bruxism related to obstructive sleep apnea: the effect of continuous positive airway pressure. Sleep Med. 2002 Nov;3(6):513-5. doi: 10.1016/s1389-9457(02)00130-2.

  PMID: 14592147 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Bruxism; Sleep Apnea Syndromes

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mieszko Adam Więckiewicz, Professor MD, PhD, DSc

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrzej Małysa, PhD

CONTACT

7717186292; andrzej.malysa@umw.edu.pl

Mieszko Więckiewicz, Professor MD, PhD, DSc

CONTACT

7717186292; mieszko.wieckiewicz@umw.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)