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Sleep Apnea Syndrome, ObstructiveOSA BruxismNCT07511946

Bruxism Induced by Obstructive Sleep Apnoea.

An observational study of Sleep Apnea Syndrome, Obstructive and Bruxism, Sleep-Related, run by Wroclaw Medical University at 1 site in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT) and Polysomnography and Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT)
How many people
80 participants
Where
1 sitePoland
Study dates
Sep 2026to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • severe systemic diseases such as cancer
  • severe neurological and autoimmune diseases
  • multiple missing teeth
  • edentulism in the upper and/or lower jaw

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mieszko Więckiewicz, Professor MD, PhD, DSc contact

7717186292 ext. +48

mieszko.wieckiewicz@umw.edu.pl

Poland1 site
  • Uniwersyteckie Centrum Stomatologiczne

    Wroclaw, Dolny Śląsk, 50-425

Other trials in Poland

About this study

Official title: Evaluation of the Relationship Between Upper Airway Volume and the Risk of Bruxism Induced by Obstructive Sleep Apnoea.

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.

Read the detailed description

The main objective of the study is to assess the relationship between upper airway volume and sleep bruxism and obstructive sleep apnea. The following null hypothesis was adopted: upper airway volume influences the intensity of sleep bruxism induced by obstructive sleep apnea.

The relationship between obstructive sleep apnea and bruxism during sleep (behavior involving increased activity of the masticatory muscles during sleep) and temporomandibular disorders (a group of diseases and disorders related to the morphology and function of the masticatory system (mainly the temporomandibular joints and masticatory muscles) is becoming increasingly well understood. However, there is a lack of data on the relationship between the three-dimensional volume of the upper airways and sleep bruxism induced by sleep apnea. Recent scientific publications have demonstrated the ability of CBCT (Cone-Beam Computed Tomography) to image the upper airway very accurately in order to examine the minimum cross-section and total volume of the upper airway in three dimensions. 3D imaging using CBCT is a simple, effective, and safe method for accurate analysis of the upper airway, which will help determine the relationship between upper airway volume and bruxism induced by obstructive sleep apnea (OSA). Modern cone beam tomography is characterized by significantly lower doses of electromagnetic radiation, averaging between 0.05 and 0.6 mSv (50-600 µSv). It is estimated that, on average, each person receives a dose of radiation from natural sources of approximately 2.4 mSv (2,400 µSv) per year. Radiation doses in diagnostic imaging, therefore, represent only a fraction of these values. It is important to be aware of what dose of radiation is harmful. It is estimated that negative health effects may occur at doses of around 200 mSv (200,000 µSv), which is significantly higher than that received during modern imaging examinations.

Materials and Methods:

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. First, each potential participant in the project will undergo a clinical and physical examination of the stomatognathic system in accordance with the international DC/TMD guidelines (Diagnostic Criteria for Temporomandibular Disorders) and in accordance with the current international consensus on bruxism at the Temporomandibular Disorders Clinic of the University Dental Centre in Wrocław. The patient will undergo a clinical examination during which systemic diseases and medications taken will be recorded.

The study will also include a range of validated questionnaires assessing psycho-emotional well-being and selected aspects related to the functioning of the stomatognathic system, including the PHQ-9 (Patient Health Questionnaire 9), PSS-10 (Perceived Stress Scale 10), GAD-7 (Generalised Anxiety Disorder 7), SWLS (Satisfaction with Life Scale), SSS-8 (Somatic Symptom Scale 8), MIDAS (The Migraine Disability Assessment Test), JFLS-8 (Jaw Functional Limitation Scale - 8), TMD Pain Screener (Temporomandibular Disorders 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 (Epworth Sleepiness Scale), PSQI (Pittsburgh Sleep Quality Index) and STOP-Bang Questionnaire. The next step will be to refer the patient for CBCT imaging, including measurements of the minimum cross-sectional area and 3D volume of the upper airways. Upper airway measurements will be performed in accordance with the protocol by Fonseca et al. The CBCT scan will take place at the University Dental Centre in Wrocław. The patient will then be referred to the Department and Clinic of Diabetology, Hypertension and Internal Medicine at the University Hospital, 213 Borowska Street, Wrocław, for a polysomnography examination. Polysomnography (PSG) is a non-invasive test comprising an EEG (electroencephalogram), ECG (electrocardiogram), EOG (electrooculogram), EMG (electromyogram), assessment of chest and abdominal movements, and measurement of blood oxygen saturation. It is used as the gold standard for diagnosing the severity of sleep apnoea by determining the AHI (Apnoea-Hypopnoea Index) and sleep bruxism by determining the BEI (Bruxism Episode Index). The polysomnography will be performed in accordance with the current guidelines of the American Academy of Sleep Medicine. During PSG, numerous other parameters relating to bodily functions during sleep are also collected. The aforementioned medical facilities possess the necessary equipment, scientific and clinical knowledge and experience to carry out the aforementioned examinations (CBCT: Planmeca Viso G7 CT scanner, Helsinki, Finland; PSG: NOX A1 sleep recorder, Iceland). The collected data will undergo thorough and specialist statistical analysis.

Anticipation Results:

By analyzing the results collected during the study and establishing probable correlations or their absence, it will be possible to understand the relationship between specific disorders and behaviors, and then counteract their development in everyday clinical work with patients with sleep bruxism around the world. According to the latest meta-analysis, this is 21% of the global population.

Being tested
Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT) and Polysomnography, Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT)
Keywords
Sleep Apnea, Bruxism, Sleep-Related
Medical subject headings
Sleep Apnea, Obstructive, Sleep Bruxism, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT) and PolysomnographyDiagnostic 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.

  • 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.

Study groups in NCT07511946
Study groupRoleWhat they receive
Study GroupThe 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.
Receives: Diagnostic Test: Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT) and Polysomnography
Control GroupThe 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.
Receives: Diagnostic Test: Upper airway volume assessment using Cone-Beam Computed Tomography (CBCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 01.04.2026-31.11.2026

Secondary outcomes (8)
  1. Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire.

    Each participant will fill in Patient Health Questionnaire - 9. PHQ-9 total score for the nine items ranges from 0 to 27.Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

    Measured: 01.04.2026-31.12.2026

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

    Each participant will fill in Generalized Anxiety Disorder -7 that consists of 7 items. Total score ranges 0-21 points. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

    Measured: 01.04.2026-31.12.2026

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

    Each participant will fill in Perceived Stress Scale -10. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. It can range from 0 to 40. Scores ranging from 0-13 would be considered low stress,14-26 would be considered moderate stress, 27-40 would be considered high perceived stress.

    Measured: 01.04.2026-31.12.2026

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

    Each participant will fill in Satisfaction With Life Scale which consist of five questions with 5 possible answers. Total score range is 35. Higher score represents higher life satisfaction. Score ranging from 5-9 as considered as extremly dissatisfied with life, 10-14 dissatisfied, 15-19 slightly dissatisfied, 20-24 slightly satisfied, 25-29 satisfied, 30-35 extremely satisfied.

    Measured: 01.04.2026-31.12.2026

  5. 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.

    Each participant will fill in Pittsburgh Sleep Quality Index. The measure consists of 19 individual items, creating 7 components that produce one global score ranging from 0 to 21, where lower scores mean better sleep quality.

    Measured: 01.04.2026-31.12.2026

  6. Relationship between bruxism and apnea risk assessed by STOP-Bang.

    Each participant will fill in STOP-Bang questionnaire. The total score ranges from 0 to 8. The lower the score is, the lower the risk of occurrence Obstructive Sleep Apnea (OSA).

    Measured: 01.04.2026-31.12.2026

  7. Relationship between bruxism and headache impact assessed by Migraine Disability Assessment questionnaire.

    Each participant will fill in Migraine Disability Assessment questionnaire. Scoring includes adding the total number of days from questions 1-5. Grading includes: grade I (little or no disability) 0-5 days, grade II (mild disability) 6-10 days, grade III (moderate disability) 11-20 days, grade IV (severe disability) more than 21 days.

    Measured: 01.04.2026-31.12.2026

  8. Relationship between bruxism and sleep apnea (OSA) by Epworth Sleepiness Scale

    Each participant will fill Epworth Sleepiness Scale (ESS), which is a validated 8-item self-administered questionnaire used to measure average daytime sleepiness and the probability of falling asleep in common situations, ranging from 0 (never) to 3 (high chance) per item. A total score of 11 or higher indicates excessive daytime sleepiness, potentially suggesting sleep disorders like apnea.

    Measured: 01.04.2026-31.12.2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07511946
Sponsor's protocol ID
SUBK.B160.25.003
Other IDs
SUBK.B160.25.003
Acronym
OSA Bruxism
Status last verified
Jan 2026
First submitted
30 Mar 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14592147

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Apnea Syndrome, Obstructive and Bruxism, Sleep-Related, run by Wroclaw Medical University at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrzej Małysa, PhD (7717186292 ext. +48, andrzej.malysa@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The relationship between obstructive sleep apnea and bruxism during sleep. (time frame: 01.04.2026-31.11.2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07511946, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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