Impact of Bruxism Related Arousals on Cardiovascular Risk in Co-morbid Insomnia and Sleep Apnea
Key facts
- Who runs it
- Wroclaw Medical University
- Where
- Poland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 119 people enrolled
- Started
- 1 Jun 2021
- Ended
- 30 Mar 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- Polysomnography
- Record updated
- 28 March 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- age between 18 and 75 years old
- suspicion of COMISA
Who cannot take part
- taking drugs that could falsify polysomnography
- drug addiction
- terminal general diseases
- severe mental disorders
- age under 18
- age over 75
- confirmed alcoholism
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- COMISA group
Patients with diagnosed COMISA.
Treatment: Polysomnography
- Healthy controlls
Healthy indyviduals.
Treatment: Polysomnography
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Impact of Bruxism Related Arousals on Cardiovascular Risk in Co-morbid Insomnia and Sleep Apnea (COMISA)
- Record updated
- 28 March 2025