Wroclaw Medical University
Wroclaw, Poland
NCT Number: NCT03083405
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).
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Wroclaw, Poland
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 01.03.2017 - 01.03.2018
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.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in Epworth scale.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in Athens scale.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in STOP-bang questionnaire.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in Pittsburgh Sleep Quality Index.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill undergo polysomnography and genetical blood tests.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in Berlin questionaire.
Time frame: 01.03.2017 - 01.03.2018
Cardiovascular risk will be assessed in each participant using ABPM.
Time frame: 01.03.2017 - 01.03.2018
Cardiovascular risk will be assessed in each participant using ECG Holter.
Time frame: 01.03.2017 - 01.03.2018
Cardiovascular risk will be assessed in each participant using heart ultrasonography.
Time frame: 01.03.2017 - 01.03.2018
Expansion of the brachial artery will be evaluated using ultrasonography Aloka Prosound Alpha 6.
Time frame: 01.03.2017 - 01.03.2018
Blood test determining levels of FT3, FT4, TSH and Anti-TPO will be conducted for each participant to evaluate the function of thyroid.
Time frame: 01.03.2017 - 01.03.2018
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.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in the scale of perceived stress - questionnaire PSS 10.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in a questionnaire assessing quality of life.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in severity level of fatigue scale.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in severity level of tiredness scale.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in Beck Depression Inventory.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in TMD pain screener, Oral Behavior Checklist. All of the participants will also undergo diagnostics in accordance to DC/TMD.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in HIT-6 questionnaire.
Time frame: 01.03.2017 - 01.03.2018
Each participant will fill in HUNT questionnaire.
Time frame: 01.03.2017 - 01.03.2018
Opipramol treatment will be implemented in patients with bruxism.
Time frame: 01.03.2017 - 01.03.2018
Each patient will undergo genetical blood test.
Wroclaw Medical University
Other
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
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