Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03083405 |
| Other study ID # |
WMU1/2017 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2017 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Wroclaw Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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). 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).
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.
