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临床试验/NCT03083405
NCT03083405Enrolling By Invitation不适用

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

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
100
试验地点
1
主要终点
Relationship between bruxism and quality of sleep assessed by polysomnography.

研究概览

简要总结

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).

详细描述

  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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Opipramol group

Patients diagnosed with SB and opipramol intervention.

干预措施: Opipramol (Drug)

SB group

Patients diagnosed with SB and no drug intervention.

Healthy controls

Patients without diagnosed SB.

结局指标

主要结局

Relationship between bruxism and quality of sleep assessed by polysomnography.

时间窗: 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.

次要结局

  • Relationship between bruxism and sleep apnea assessed by polysomnography and genetical tests.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and quality of sleep assessed by Epworth scale.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and sleep apnea assessed by Berlin questionaire.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and thyroid function assessed by clinical tests of blood.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and cardiovascular risk assessed by 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.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and mental status assessed by Beck Depression Inventory(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and headaches assessed by HUNT questionnaire.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and quality of sleep assessed by Athens scale.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and cardiovascular risk assessed by ECG Holter.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism quality of life and mental status assessed by the severity level of fatigue scale.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and quality of sleep assessed by STOP-bang questionnaire.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and quality of sleep assessed by Pittsburgh Sleep Quality Index.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism, quality of life and mental status assessed by the questionnaire assessing quality of life.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and temporomandibular disorders (TMD).(01.03.2017 - 01.03.2018)
  • Is bruxism genetically determined?(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and cardiovascular risk assessed by ABPM.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and masticatory muscle activity assessed by electromyography.(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.(01.03.2017 - 01.03.2018)
  • Relationship between bruxism and headaches assessed by Headache Impact Test - 6 (HIT-6).(01.03.2017 - 01.03.2018)
  • Relationship between bruxism quality of life and mental status assessed by the severity level of tiredness scale.(01.03.2017 - 01.03.2018)
  • Effect of treatment with opipramol on bruxism episodes.(01.03.2017 - 01.03.2018)

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanna Smardz

Principal Investigator

Wroclaw Medical University

研究点 (1)

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