Clinical trial NCT04214561: Relationship Between Selected Parameters and Bruxism
Official title: Assessment of Sleep Structure, Selected Blood Parameters, Respiratory Function, Genotype, Phenotype, Pain, Anxiety and Psychosomatization in Patients With Bruxism
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sleep Bruxism
Sleep Disorder
Psychosomatic Disorder
Pain
Anxiety
Mental Status Change
Temporomandibular Disorder
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with probable sleep bruxism referred to the Department of Internal Medicine, Occupational Diseases and Hypertension and Clinical Oncology for polysomnography. Healthy controls.

Brief summary: Bruxism is a common phenomenon. It is estimated that its prevalence in the adult population is 8-31%. Bruxism occurring during sleep is the activity of the masticatory muscles that appear during sleep, which can be rhythmic or phased and is not a movement disorder or sleep disorder in healthy people. It is currently believed that bruxism should not be considered a disorder. In healthy people, it is treated rather as behavior, which may be a risk factor for pathological clinical implications or a protective factor in the presence of other disease entities. The most common symptoms of bruxism include: pathological wear and tooth sensitivity, periodontal and oral mucosa damage, myalgia in the stomatognathic system, headache and prosthetic restoration damage. However, due to nocturnal occurrence, bruxism symptoms may go unnoticed for a long time, which means that patients are often unaware of this behavior. The etiology of bruxism is multifactorial and not fully understood. It is currently believed that it can be caused by genetic, psychological and exogenous factors. Due to the unclear etiology of bruxism, it is so important to conduct research that allows making a certain diagnosis and finding the causes of this phenomenon

Detailed description: Sleep breathing disorders are a frequent and serious health problem in the Polish population. Obstructive sleep apnea (OSA) is a common disorder. The essence of OSA is repeated episodes of airway obstruction that occur repeatedly during sleep, resulting in a decrease in the level of partial oxygen in the blood. Increased tension in the upper respiratory muscles and throat vibrations often result in very loud snoring. Apnea episodes end with awakenings that cause sleep fragmentation, deep sleep deficiency, and REM phase. Such episodes occur repeatedly, over a dozen or even several dozen times per hour of sleep. The consequence of episodes of obstruction and fragmentation of sleep is ineffective, restless sleep, pathological daytime sleepiness, falling asleep against your own will, awakening with a feeling of stopping breath, shortness of breath or choking. Sleep fragmentation and repetitive episodes of hypoxia result in poor quality of life, chronic fatigue and an increased risk of traffic accidents. The direct consequences of apnea are blood hypoxia, increased heart rate and increased blood pressure. Common complications of OSA are hypertension, stroke, arrhythmias, coronary artery disease, pulmonary hypertension and heart failure. Untreated OSA increases the risk of premature death, especially in men under 50 years of age, contributing to the development of vascular endothelial dysfunction and an increase in cardiovascular risk.

The causal relationship between bruxism and apnea has not been clearly established so far. There is also a lack of research on the contribution of genetic factors to the emergence and severity of both conditions.The project will be implemented at the Sleep Laboratory at the Clinic of Internal, Occupational Diseases and Hypertension of the Medical University of Wrocław, which has a technical room with three computer stations, three polysomnographic devices. About 100 patients will be examined at the Department of Internal Diseases, Occupational and Hypertension and Clinical Oncology because of suspected bruxism during sleep. The full polysomnographic examination with video recording will be directed to patients from the Chewing Organ Dysfunction Clinic operating at the Department of Experimental Dentistry at the Medical University of Wrocław, who will be interviewed and have a comprehensive external and intra-oral examination according to Diagnostic Criteria for Temporomandibular Disorders (DC / TMD) and based on the guidelines of the American Academy of Sleep Medicine International Classification of Sleep Disorders, probable bruxism during sleep will be diagnosed. Polysomnograms will be evaluated in 30-second folds, according to standard sleep criteria. PSG results will include data on sleep latency, total sleep time (TST) and sleep performance (%) as well as assessment of the N1, N2, N3 and REM phases. Respiratory pathological events will be assessed according to the American Sleep Academy standards. Apnea will be defined as no airflow through the airways for more than 10 seconds. Shortness of breath will be defined as a reduction in respiratory amplitude by more than 30% for more than 10 seconds, with subsequent blood desaturation by more than 3%, or with subsequent awakening. The activity of the masticatory muscles during the examination will be assessed on the basis of EMG recording from electrodes placed on the chin and symmetrically in the vicinity of the masseter muscles attachments. As episodes of bruxism, episodes of rhythmic activity of the masseter muscles, often accompanied by grinding or knocking noises and characteristic movements in the orofacial region occurring after a minimum interval of three seconds from the last muscular activity, will be qualified. Bruxism episodes will be assessed quantitatively using the BEI (Bruxism Episodes Index) rating the number of bruxism episodes per hour of patient's sleep, and qualitatively for phase, tonic and mixed episodes. The results will then be analyzed for the incidence of RMMA directly related to bruxism episodes and their relationship to sleep apnea episodes, changes in blood pressure and heart rhythm to determine time and cause-effect relationships.

In addition, we will carry out the following surveys: ISI Insomnia Severity Scale, KPS sense of stress questionnaire , TEC Traumatic Experience Checklist. , mini COPE stress management questionnaire, CECS Courtauld Emotional Control Scale, AIS Accteptance of Illness Scale ,BAI Beck Anxiety Index, Short Questionnaire for Measuring the Big Five IPIP-BFM-20, McGill Pain Questionnaire, GCSP Graded Chronic Pain Scale. , PHQ-9 Patient Health Questionnaire, Pittsburgh Sleep Quality Index PSQI, STOP-Bang Apnea Risk Questionnaire, Beck Depression Inventory, PSS-10 Perceived Stress Scale -10, HIT-6 Headache Impact Test,GAD-7 Generalized Anxiety Disorder ,MIDAS scale for assessing functioning disorders in migraine.

Each patient will also be subjected to genetic blood laboratory tests to determine the occurrence of specific genotypes and phenotypes occurring in patients with bruxism.

The tests will be carried out in accordance with the CONSORTated (CONsolidated Standards of Reporting Trials) guidelines for RCT (Randomized Controlled Trial). Expected effects:

1. Assessment of the incidence of bruxism during sleep in patients with breathing disorders during sleep
2. Determination of changes in sleep structure in patients with bruxism.
3. Assessment of possible genetic basis in patients with bruxism
4. Assessment of psychosomatization in patients with bruxism.
5. Assessment of the level of anxiety and pain felt in patients with bruxism.

Eligibility criteria: Inclusion Criteria:

* diagnosed sleep bruxism
* age between 18 and 70

Exclusion Criteria:

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

Primary outcomes:
measure: Relationship between bruxism and sleep structure by polysomnography.
timeFrame: 15.10.2019 - 31.12.2020
Secondary outcomes:
measure: Relationship between bruxism and insomnia assessed by Insomnia Severity Scale.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and sense of stress assessed by Sense of stress questionnaire - KPS questionnaire measuring the structure of stress sensations. sense of stress questionnaire.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and trauma asessed by Traumatic Experience Checklist.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and coping with stress assessed by mini COPE- inventory to measure stress management.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and emotional controll assessed by Courtauld Emotional Control Scale.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and illness accteptance assessed by Accteptance of Illness Scale.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and anxiety assessed by Beck Anxiety Index.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and personality assessed by International Personality Item Pool-Big Five Markers-20.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and pain assessed by McGill questionnaire.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and pain assessed by Graded Chronic Pain Scale.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and depression assessed by Patient Health Questionnaire - 9.
timeFrame: 15.10.2019 - 31.12.2020
measure: 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.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and apnea risk assessed by STOP-Bang.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and depression assessed by Beck Depression Inventory.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and perceived stress assessed by Perceived Stress Scale - 10.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and headache assessed by Headache Impact Test - 6.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and anxiety assessed by Generalized Anxiety Disorder -7.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and headache impact assessed by Migraine Disability Assessment questionnaire.
timeFrame: 15.10.2019 - 31.12.2020
measure: Relationship between bruxism and genotype and fenotype assessed in blood test.
timeFrame: 15.10.2019 - 31.12.2020
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: Wroclaw Medical University
name: Mieszko Wieckiewicz, DMD, PhD
role: STUDY_CHAIR
affiliation: Wroclaw Medical University
name: Helena Martynowicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: