跳至主要内容
临床试验/NCT04937036
NCT04937036已完成不适用

Evaluation of Impact of Bruxism Related Arousals on Cardiovascular Risk in Co-morbid Insomnia and Sleep Apnea (COMISA)

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
119
试验地点
1
主要终点
The meaning of arousals in relationships between sleep bruxism, obstructive sleep apnea, insomnia and COMISA,

研究概览

简要总结

Sleep disordered breathing is a common and serious health problem. According to epidemiological data, it may affect about 20% of adult population. The majority is not aware of the disease. The most common sleep disorder is obstructive sleep apnea (OSA). The essence of OSA are the episodes of airway obstruction repeated many times during sleep, as a result of which the level of partial oxygen in the blood decreases. Apnea episodes end up waking from sleep, causing sleep fragmentation, deep sleep and REM deficiency. Frequent complications of OSA are hypertension, stroke, cardiac arrhythmia, coronary artery disease and pulmonary hypertension.

Comorbid Insomnia and Sleep Apnea (COMISA) is a highly prevalent and debilitating disorder that causes additional disturbances in sleep, daytime functioning, and quality of life for patients, and is a significant diagnostic and therapeutic problem for clinicians. Although the presence of COMISA was first noticed by Christian Guilleminault and his colleagues in 1973, it received very little research attention for almost three decades. There is still lack ofclinical trials concerning this topic.

An additional problem in apnea patients is the increased incidence of bruxism. Bruxism is associated with increased masticatory muscle activity during sleep, which may be phased or tonic. It is estimated that the incidence of bruxism in the adult population is 13%. The most common symptoms of bruxism include: pathological wear and tooth sensitivity, damage to the periodontium and oral mucosa, muscle pain in the stomatognathic system, headaches and damage to prosthetic restorations. However, the symptoms of bruxism can go unnoticed for a long time, leaving patients often unaware of the problem.

The aim of this project is:

  1. to determine the prevalence of sleep bruxism in COMISA, OSA and insomnia,
  2. to examine of arousals (type, frequency) in COMISA, OSA and insomnia,
  3. to investigate the relationship between arousals and blood pressure values and variability, arrhythmias, sinus rhythm variability, vascular endothelial dysfunction, cardiovascular risk in COMISA, OSA and insomnia.

详细描述

I. Introduction

Sleep disordered breathing is a common and serious health problem. According to epidemiological data, it may affect about 20% of the adult population, the majority is not aware of the disease. The most common sleep disorder is obstructive sleep apnea (OSA). The essence of OSA are the episodes of airway obstruction repeated many times during sleep, as a result of which the level of partial oxygen in the blood decreases. Apnea episodes end up with arousal, causing sleep fragmentation, deep sleep and REM deficiency. The consequence of episodes of OSA and fragmentation of sleep is ineffective, non-restful sleep, pathological daytime sleepiness, shortness of breath or choking. Fragmentation of sleep and repeated episodes of hypoxia result in a deterioration of the quality of life, chronic fatigue, and an increased risk of road accidents. The immediate consequences of apnea are hypoxia, awakening, increased heart rate, and an increase in blood pressure. Common complications of OSA include high blood pressure, stroke, arrhythmias, coronary artery disease, pulmonary hypertension, and heart failure. Untreated OSA increases the risk of premature death, especially in men under 50, contributing to the development of vascular endothelial dysfunction and increasing cardiovascular risk.

Comorbid Insomnia and Sleep Apnea (COMISA) is a highly prevalent and debilitating disorder that causes additional disturbances in sleep, daytime functioning, and quality of life for patients, and is a significant diagnostic and therapeutic problem for clinicians. Although the presence of COMISA was first noticed by Christian Guilleminault and his colleagues in 1973, it received very little research attention for almost three decades. There is still lack ofclinical trials concerning this topic.

An additional problem in OSA patients is the increased incidence of bruxism. Bruxism is associated with increased masticatory muscle activity during sleep, which may be phasic or tonic. It is estimated that the incidence of bruxism in the adult population is 13%. The most common symptoms of bruxism include: pathological wear and tooth sensitivity, damage to the periodontium and oral mucosa, muscle pain, headaches and damage to prosthetic restorations. However, the symptoms of bruxism can go unnoticed for a long time, leaving patients often unaware of the problem. There are two different types of bruxism: sleep bruxism (SB) and awake bruxism (AB). The etiology of bruxism is multifactorial and not fully understood, it is believed that it may be modulated by biological, psychological and exogenous factors. Bruxism may also be a protective factor in patients with disordered breathing during sleep. A key aspect of this relationship is likely related to arousals.

So far, it has not been possible to clearly define the exact cause-and-effect relationship between obstructive sleep apnea, insomnia and sleep bruxism. The relationship with cardiovascular risk is also unclear.More research is needed to clarify the relationship between these phenomena.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 75 years old
  • suspicion of COMISA

排除标准

  • age under 18
  • age over 75
  • terminal general diseases
  • severe mental disorders
  • taking drugs that could falsify polysomnography
  • confirmed alcoholism
  • drug addiction

结局指标

主要结局

The meaning of arousals in relationships between sleep bruxism, obstructive sleep apnea, insomnia and COMISA,

时间窗: 01.07.2021-31.12.2022

Each participant will undergo audio-video polysomnography to assess sleep bruxism, sleep-related breathing disorders and other sleep parameters (especially arousals: type, frequency).

The incidence of sleep bruxism in obstructive sleep apnea, insomnia and COMISA.

时间窗: 01.07.2021-31.12.2022

Each participant will undergo audio-video polysomnography to assess sleep bruxism, sleep-related breathing disorders and other sleep parameters. Polysomnograms will be evaluated in a 30-second contributions, according to standard sleep criteria.

次要结局

  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and central sensitization assessed by Central Sensitization Inventory.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and headache assessed by Migraine Disability Assessment Test (MIDAS).(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea and insomnia assessed by Insomnia Severity Index.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, insomnia and apnea risk assessed by STOP-Bang.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and perceived stress assessed by Perceived Stress Scale - 10.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and quality of sleep assessed by Epworth Sleepiness Scale.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and satisfaction with life assessed by Satisfaction With Life Scale.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and pain assessed by Graded Chronic Pain Scale.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea and insomnia assessed by Athens Insomnia Scale.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and sleep quality assessed by Pittsburgh Sleep Quality Index - a self-report questionnaire that assesses sleep quality over a 1-month time interval.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and depression assessed by Patient Health Questionnaire - 9.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and anxiety assessed by Generalized Anxiety Disorder -7.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and blood parameters assessed by blood tests.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and somatic symptoms assessed by Somatic Symptom Scale - 8.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and chronotype assessed by Munich Chronotype Questionnaire (MCTQ).(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and cardiovascular risk assessed by ambulatory blood pressure measurement (ABPM).(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and cardiovascular risk assessed by ECG Holter.(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and cardiovascular risk assessed by cardiovascular risk assessment tool (SCORE).(01.07.2021-31.12.2022)
  • Relationship between sleep bruxism, obstructive sleep apnea, COMISA and cardiovascular risk assessed by central blood pressure measurement.(01.07.2021-31.12.2022)

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

Investigator

Wroclaw Medical University

研究点 (1)

Loading locations...

相似试验