Selected Disorders and Sleep Bruxism

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Hypertension; Sleep Apnea; Cardiovascular Risk Factor; Sleep Disorders; Temporomandibular Disorder; Sleep Bruxism; Thyroid Dysfunction; Mental Status Change
• Intervention / Treatment: Drug: Opipramol

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Poland
  • Wrocław, Poland
    • Wroclaw Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Opipramol group; Patients diagnosed with SB and opipramol intervention.	Drug: Opipramol; 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.
SB group; Patients diagnosed with SB and no drug intervention.
Healthy controls; Patients without diagnosed SB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	01.03.2017 - 01.03.2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between bruxism and quality of sleep assessed by Epworth scale.	Each participant will fill in Epworth scale.	01.03.2017 - 01.03.2018
Relationship between bruxism and quality of sleep assessed by Athens scale.	Each participant will fill in Athens scale.	01.03.2017 - 01.03.2018
Relationship between bruxism and quality of sleep assessed by STOP-bang questionnaire.	Each participant will fill in STOP-bang questionnaire.	01.03.2017 - 01.03.2018
Relationship between bruxism and quality of sleep assessed by Pittsburgh Sleep Quality Index.	Each participant will fill in Pittsburgh Sleep Quality Index.	01.03.2017 - 01.03.2018
Relationship between bruxism and sleep apnea assessed by polysomnography and genetical tests.	Each participant will fill undergo polysomnography and genetical blood tests.	01.03.2017 - 01.03.2018
Relationship between bruxism and sleep apnea assessed by Berlin questionaire.	Each participant will fill in Berlin questionaire.	01.03.2017 - 01.03.2018
Relationship between bruxism and cardiovascular risk assessed by ABPM.	Cardiovascular risk will be assessed in each participant using ABPM.	01.03.2017 - 01.03.2018
Relationship between bruxism and cardiovascular risk assessed by ECG Holter.	Cardiovascular risk will be assessed in each participant using ECG Holter.	01.03.2017 - 01.03.2018
Relationship between bruxism and cardiovascular risk assessed by heart ultrasonography.	Cardiovascular risk will be assessed in each participant using heart ultrasonography.	01.03.2017 - 01.03.2018
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.	01.03.2017 - 01.03.2018
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.	01.03.2017 - 01.03.2018
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.	01.03.2017 - 01.03.2018
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.	01.03.2017 - 01.03.2018
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.	01.03.2017 - 01.03.2018
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.	01.03.2017 - 01.03.2018
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.	01.03.2017 - 01.03.2018
Relationship between bruxism and mental status assessed by Beck Depression Inventory	Each participant will fill in Beck Depression Inventory.	01.03.2017 - 01.03.2018
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.	01.03.2017 - 01.03.2018
Relationship between bruxism and headaches assessed by Headache Impact Test - 6 (HIT-6).	Each participant will fill in HIT-6 questionnaire.	01.03.2017 - 01.03.2018
Relationship between bruxism and headaches assessed by HUNT questionnaire.	Each participant will fill in HUNT questionnaire.	01.03.2017 - 01.03.2018
Effect of treatment with opipramol on bruxism episodes.	Opipramol treatment will be implemented in patients with bruxism.	01.03.2017 - 01.03.2018
Is bruxism genetically determined?	Each patient will undergo genetical blood test.	01.03.2017 - 01.03.2018

Collaborators and Investigators

• Sponsor: Wroclaw Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2017
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: February 19, 2017
• First Submitted That Met QC Criteria: March 13, 2017
• First Posted (ACTUAL): March 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Parasomnias; Tooth Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Cardiovascular Diseases; Disease; Sleep Wake Disorders; Bruxism; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Sleep Bruxism; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Opipramol
• Other Study ID Numbers: WMU1/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No