Clinical trial

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

Name
WMU1/2017
Description
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).
Trial arms
Trial start
2017-04-20
Estimated PCD
2024-12-01
Trial end
2024-12-01
Treatment
Opipramol
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.
Arms:
Opipramol group
Size
100
Primary endpoint
Relationship between bruxism and quality of sleep assessed by polysomnography.
01.03.2017 - 01.03.2018
Eligibility criteria
Inclusion Criteria: * diagnosed sleep bruxism * full dentition * single tooth loss * age between 18 and 70 Exclusion Criteria: * age under 18 * age over 70 * terminal general diseases * severe mental disorders * edentulism * taking drugs that could falsify polysomnography * confirmed alcoholism * drug addiction
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-05-07

1 organization

1 product

9 indications

Product
Opipramol
Indication
Bruxism
Indication
Hypertension
Indication
Sleep Apnea
Indication
Sleep Disorders