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Sleep BruxismNCT03083405

Selected Disorders and Sleep Bruxism

An observational study of Sleep Bruxism and Hypertension, run by Wroclaw Medical University at 1 site in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Sleep apnea is a common and serious health problem in the Polish population. According to epidemiological data problem concerns about 7% of the adult population. The most common sleep disorder is obstructive sleep apnea (OSA). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Bruxism, Hypertension, Thyroid Dysfunction
What is being tested?
Opipramol
How many people
100 participants
Where
1 sitePoland
Study dates
20 Apr 2017to Dec 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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients from the Clinic of Prosthodontics operating at the Department of Prosthodontics, Medical University in Wroclaw and other dental institutions diagnosed with sleep bruxism using Diagnostic Criteria for temporomandibular Disorders (DC / TMD). Patients referred to the Department of Internal Medicine, Occupational Diseases and Hypertension and Clinical Oncology for suspected sleep apnea and bruxism. Healthy controls.

Who may be able to join

  • diagnosed sleep bruxism
  • full dentition
  • single tooth loss
  • age between 18 and 70

Who cannot join

  • age under 18
  • age over 70
  • terminal general diseases
  • severe mental disorders
  • edentulism
  • taking drugs that could falsify polysomnography
  • confirmed alcoholism
  • drug addiction

Trial locations and contacts

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

Poland1 site
  • Wroclaw Medical University

    Wroclaw

Other trials in Poland

About this study

Official title: Evaluation of the Quality of Sleep, Endothelial Function, Cardiovascular Risk, Thyroid Function, a Function of Masticatory Muscles and Psycho-emotional State of Patients With Sleep Bruxism

Sleep apnea is a common and serious health problem in the Polish population. According to epidemiological data problem concerns about 7% of the adult population. The most common sleep disorder is obstructive sleep apnea (OSA). The consequence of episodes of airway obstruction and sleep fragmentation is an inefficient sleep, pathological daytime sleepiness, falling asleep involuntarily, awakening with feelings of shortness of breath or throttling. The direct consequences of sleep apnea are hypoxia, increased heart rate and increased blood pressure. Frequent complications of OSA are hypertension, stroke, cardiac arrhythmia, coronary artery disease and pulmonary hypertension. An additional problem in patients with sleep apnea is an increased incidence of bruxism. Bruxism is a common problem; reports of prevalence range from 8-31% in the general population. The most common symptoms of bruxism include: hypersensitive teeth, tooth wear, damage to dental restorations (e.g. crowns and fillings), damage to periodontal and oral mucosa, masticatory muscle pain and headaches. The etiology of bruxism is multifactorial and not fully understood. It can be caused by biologic, psychologic and exogenous factors. Arousals during the apnea episodes are considered to be a major cause of sleep bruxism in OSA patients. The relationship between OSA and sleep bruxism is still not clearly defined. Further research is needed to help explain the relationship between these two phenomena, which will enable further therapy in patients with coexisting OSA and sleep bruxism (SB).

Read the detailed description
  1. Introduction Sleep apnea is a common and serious health problem in the Polish population. According to epidemiological data problem concerns about 7% of the adult population. The most common sleep disorder is obstructive sleep apnea (OBS). The essences of OBS are episodes of airway obstruction repeated many times during sleep. As a result the oxygen level in blood decreases. The result of increased muscle tension of upper respiratory tract and throat vibrations is a very loud snoring restoring breath. Episodes of apnea with arousals cause sleep fragmentation, shortage of deep sleep and rapid eye movement (REM). Such episodes occur repeatedly, several, or even dozens of times per hour of sleep. The consequence of episodes of airway obstruction and sleep fragmentation is an inefficient, lack of rest sleep, pathological daytime sleepiness, falling asleep involuntarily, awakening with feelings of shortness of breath or throttling. Fragmentation of sleep and repeated episodes of hypoxia result in deterioration of quality of life, chronic fatigue and an increased risk of communication accidents. The direct consequences of sleep apnea are hypoxia, awakening, increased heart rate and increased blood pressure. Frequent complications of obstructive sleep apnea (OSA) are hypertension, stroke, cardiac arrhythmia, coronary artery disease, pulmonary hypertension and heart failure. If left untreated, OSA contributes to the development of vascular endothelial dysfunction and increases the risk of premature death, especially in men under age of 50. An additional problem in patients with sleep apnea is an increased incidence of bruxism. Bruxism is a common problem; reports of prevalence range from 8-31% in the general population. The most common symptoms of bruxism include: hypersensitive teeth, tooth wear, damage to dental restorations (e.g. crowns and fillings), damage to periodontal and oral mucosa, masticatory muscle pain and headaches. Symptoms of bruxism may go unnoticed for a long time, which implies that patients often don't know about their condition. There are two different types of bruxism: Sleep Bruxism (SB) and Awake Bruxism (AB). Type SB consists of involuntary, episodic and rhythmic activity of masticatory muscles (Rhythmic Masticatory Muscle Activity / RMMA). The etiology of bruxism is multifactorial and not fully understood.It can be caused by biologic, psychologic and exogenous factors. Arousals during the apnea episodes are considered to be a major cause of sleep bruxism in OSA patients. The relationship between obstructive sleep apnea and sleep bruxism is still not clearly defined. Further research is needed to help explain the relationship between these two phenomena, which will enable further therapy in patients with coexisting OSA and SB.
  2. Aim The aim of the study is evaluation of the quality of sleep, endothelial function, cardiovascular risk, thyroid function, a function of masticatory muscles, psycho-emotional status, genetic predispositions and drug effectiveness in patients with bruxism.
  3. Methods The project will take place in the Sleep Laboratory at the Department of Internal Medicine, Occupational Diseases and Hypertension Medical University in Wroclaw. About 100 patients referred to the Department of Internal Medicine, Occupational Diseases and Hypertension and Clinical Oncology for suspected sleep apnea and bruxism will be included.

Patients from the Clinic of Prosthodontics operating at the Department of Prosthodontics, Medical University in Wroclaw and other dental institutions diagnosed using Diagnostic Criteria for Temporomandibular Disorders (DC / TMD) and Criteria of American Academy of Sleep Medicine International Classification of Sleep Disorders ICSD-3 evaluating bruxism will undergo polysomnography (PSG) with video recording.

Polysomnograms will be evaluated in a 30-second contributions, according to standard sleep criteria. PSG results will contain data on the latency of sleep, total sleep time (TST), sleep efficiency (%) and an evaluation of phases N1, N2, N3 and REM. Pathological respiratory events will be evaluated in accordance with the standards of the American Academy of Sleep. Apnea is defined as the absence of airflow through the respiratory tract by more than 10 seconds. The shallowness of breathing is defined as a decrease in respiratory amplitude by more than 30% for more than 10 seconds, with subsequent desaturation of more than 3% or subsequent awakening.

Then, to evaluate the function of vascular endothelium in patients expansion of the brachial artery using ultrasonography Aloka Prosound Alpha 6, using the guidelines of the international working group studying reactivity of the brachial artery will be explored. Ultrasound of the heart, Electrocardiography Holter and Ambulatory blood pressure monitoring (ABPM) will be performed in each patient. In addition, researchers will execute surveys: Epworth Scale, Athens Scale, STOP-Bang Scale, Berlin questionnaire, the severity level of fatigue / tiredness scale, a questionnaire assessing quality of life, the scale of perceived stress - questionnaire PSS 10 and questionnaires Oral Behavior Checklist (OBC) and Pittsburgh Sleep Quality index (PSQI). Headache episodes will be assessed using Headache Impact Test - 6 (HIT-6) and HUNT questionnaires.

Each patient will be performed laboratory blood tests to determine levels of FT3, FT4 and TSH in order to evaluate the relationship between RMMA and thyroid disease and genetical tests. At the same time the relationship between bruxism, psycho-emotional state and sleep quality will be evaluated through questionnaires PSS10, OBC and PSQI.

Masticatory muscle activity during the study will be assessed on the basis of the record coming from electromyography electrodes placed on the beard and symmetrically around the masseter muscle attachments. The results will then be analyzed for the incidence RMMA directly related to episodes of bruxism and their relation to episodes of sleep apnea, changes in blood pressure and heart rate to determine the prevalence of cause-effect relationships.

Being tested
Opipramol
Medical subject headings
Sleep Bruxism, Hypertension, Sleep Apnea Syndromes, Sleep Wake Disorders, Cardiovascular Diseases, Temporomandibular Joint Disorders

What participants receive

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

  • OpipramolDrug

    The study group will get a drug to decrease bruxism activity. Group will be evaluated using polysomnography included rhythmic masticatory muscle activity registration before and after intervention.

Study groups in NCT03083405
Study groupRoleWhat they receive
Opipramol groupPatients diagnosed with SB and opipramol intervention.
Receives: Drug: Opipramol
SB groupPatients diagnosed with SB and no drug intervention.
Healthy controlsPatients without diagnosed SB.

What is being measured

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

  1. Relationship between bruxism and quality of sleep assessed by polysomnography.

    Polysomnograms will be evaluated in a 30-second contributions, according to standard sleep criteria. PSG results will contain data on the latency of sleep, total sleep time (TST), sleep efficiency (%) and an evaluation of phases N1, N2, N3 and REM.

    Measured: 01.03.2017 - 01.03.2018

Secondary outcomes (22)
  1. Relationship between bruxism and quality of sleep assessed by Epworth scale.

    Each participant will fill in Epworth scale.

    Measured: 01.03.2017 - 01.03.2018

  2. Relationship between bruxism and quality of sleep assessed by Athens scale.

    Each participant will fill in Athens scale.

    Measured: 01.03.2017 - 01.03.2018

  3. Relationship between bruxism and quality of sleep assessed by STOP-bang questionnaire.

    Each participant will fill in STOP-bang questionnaire.

    Measured: 01.03.2017 - 01.03.2018

  4. Relationship between bruxism and quality of sleep assessed by Pittsburgh Sleep Quality Index.

    Each participant will fill in Pittsburgh Sleep Quality Index.

    Measured: 01.03.2017 - 01.03.2018

  5. Relationship between bruxism and sleep apnea assessed by polysomnography and genetical tests.

    Each participant will fill undergo polysomnography and genetical blood tests.

    Measured: 01.03.2017 - 01.03.2018

  6. Relationship between bruxism and sleep apnea assessed by Berlin questionaire.

    Each participant will fill in Berlin questionaire.

    Measured: 01.03.2017 - 01.03.2018

  7. Relationship between bruxism and cardiovascular risk assessed by ABPM.

    Cardiovascular risk will be assessed in each participant using ABPM.

    Measured: 01.03.2017 - 01.03.2018

  8. Relationship between bruxism and cardiovascular risk assessed by ECG Holter.

    Cardiovascular risk will be assessed in each participant using ECG Holter.

    Measured: 01.03.2017 - 01.03.2018

  9. Relationship between bruxism and cardiovascular risk assessed by heart ultrasonography.

    Cardiovascular risk will be assessed in each participant using heart ultrasonography.

    Measured: 01.03.2017 - 01.03.2018

  10. Relationship between bruxism and the function of vascular endothelium assessed by expansion of the brachial artery using ultrasonography.

    Expansion of the brachial artery will be evaluated using ultrasonography Aloka Prosound Alpha 6.

    Measured: 01.03.2017 - 01.03.2018

  11. Relationship between bruxism and thyroid function assessed by clinical tests of blood.

    Blood test determining levels of FT3, FT4, TSH and Anti-TPO will be conducted for each participant to evaluate the function of thyroid.

    Measured: 01.03.2017 - 01.03.2018

  12. Relationship between bruxism and masticatory muscle activity assessed by electromyography.

    Masticatory muscle activity during the study will be assessed on the basis of the record coming from EMG electrodes placed on the beard and symmetrically around the masseter muscle attachments.

    Measured: 01.03.2017 - 01.03.2018

  13. Relationship between bruxism, quality of life and mental status assessed by the scale of perceived stress - questionnaire PSS 10.

    Each participant will fill in the scale of perceived stress - questionnaire PSS 10.

    Measured: 01.03.2017 - 01.03.2018

  14. Relationship between bruxism, quality of life and mental status assessed by the questionnaire assessing quality of life.

    Each participant will fill in a questionnaire assessing quality of life.

    Measured: 01.03.2017 - 01.03.2018

  15. Relationship between bruxism quality of life and mental status assessed by the severity level of fatigue scale.

    Each participant will fill in severity level of fatigue scale.

    Measured: 01.03.2017 - 01.03.2018

  16. Relationship between bruxism quality of life and mental status assessed by the severity level of tiredness scale.

    Each participant will fill in severity level of tiredness scale.

    Measured: 01.03.2017 - 01.03.2018

  17. Relationship between bruxism and mental status assessed by Beck Depression Inventory

    Each participant will fill in Beck Depression Inventory.

    Measured: 01.03.2017 - 01.03.2018

  18. Relationship between bruxism and temporomandibular disorders (TMD).

    Each participant will fill in TMD pain screener, Oral Behavior Checklist. All of the participants will also undergo diagnostics in accordance to DC/TMD.

    Measured: 01.03.2017 - 01.03.2018

  19. Relationship between bruxism and headaches assessed by Headache Impact Test - 6 (HIT-6).

    Each participant will fill in HIT-6 questionnaire.

    Measured: 01.03.2017 - 01.03.2018

  20. Relationship between bruxism and headaches assessed by HUNT questionnaire.

    Each participant will fill in HUNT questionnaire.

    Measured: 01.03.2017 - 01.03.2018

  21. Effect of treatment with opipramol on bruxism episodes.

    Opipramol treatment will be implemented in patients with bruxism.

    Measured: 01.03.2017 - 01.03.2018

  22. Is bruxism genetically determined?

    Each patient will undergo genetical blood test.

    Measured: 01.03.2017 - 01.03.2018

Timeline

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

  1. First posted20 Mar 2017
  2. Study start20 Apr 2017
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03083405
Sponsor's protocol ID
WMU1/2017
Status last verified
Mar 2026
First submitted
19 Feb 2017
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Martynowicz H, Bort M, Nowacki D, Frosztega W, Przegralek J, Nowak J, Madziarska K, Wieckiewicz M. Association of simple snoring and myogenous temporomandibular disorders based on polysomnographic examination. J Oral Facial Pain Headache. 2026 Mar;40(2):1-13. doi: 10.22514/jofph.2026.017. Epub 2026 Mar 12.

    PubMed 41914053
  • Wieczorek T, Wieckiewicz M, Smardz J, Wojakowska A, Michalek-Zrabkowska M, Mazur G, Martynowicz H. Sleep structure in sleep bruxism: A polysomnographic study including bruxism activity phenotypes across sleep stages. J Sleep Res. 2020 Dec;29(6):e13028. doi: 10.1111/jsr.13028. Epub 2020 Mar 11.

    PubMed 32160378
  • Smardz J, Martynowicz H, Wojakowska A, Michalek-Zrabkowska M, Mazur G, Wieczorek T, Wieckiewicz M. The meaning of the masticatory muscle tonic-type electromyographic pathway correlated with sleep bruxism and sleep-related breathing disorders - A polysomnographic study. Sleep Med. 2020 Apr;68:131-137. doi: 10.1016/j.sleep.2019.08.025. Epub 2019 Oct 2.

    PubMed 32035303
  • Martynowicz H, Smardz J, Michalek-Zrabkowska M, Gac P, Poreba R, Wojakowska A, Mazur G, Wieckiewicz M. Evaluation of Relationship Between Sleep Bruxism and Headache Impact Test-6 (HIT-6) Scores: A Polysomnographic Study. Front Neurol. 2019 May 14;10:487. doi: 10.3389/fneur.2019.00487. eCollection 2019.

    PubMed 31139138
  • Smardz J, Martynowicz H, Michalek-Zrabkowska M, Wojakowska A, Mazur G, Winocur E, Wieckiewicz M. Sleep Bruxism and Occurrence of Temporomandibular Disorders-Related Pain: A Polysomnographic Study. Front Neurol. 2019 Mar 11;10:168. doi: 10.3389/fneur.2019.00168. eCollection 2019.

    PubMed 30915015

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Bruxism and Hypertension, 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 8 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: enrolling by invitation, as of the sponsor's last update on 6 Mar 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship between bruxism and quality of sleep assessed by polysomnography. (time frame: 01.03.2017 - 01.03.2018). 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 NCT03083405, which also lists 5 linked publications.

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 6 Mar 2026.

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