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

NCT04937036 | Completed

• 1 other identifier: WMU1/2021
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.to determine the prevalence of sleep bruxism in COMISA, OSA and insomnia,
2. 2.to examine of arousals (type, frequency) in COMISA, OSA and insomnia,
3. 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.

Conditions

Sleep Apnea; Sleep Bruxism; Sleep Disorder; Insomnia; Comorbidities and Coexisting Conditions; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

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

  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.

  01.07.2021-31.12.2022

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

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

  01.07.2021-31.12.2022

Secondary Outcomes (19)

• 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 and insomnia assessed by Insomnia Severity Index.

  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, COMISA and depression assessed by Patient Health Questionnaire - 9.

  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

Study Arms (2)

COMISA group

Patients with diagnosed COMISA.

Diagnostic Test: Polysomnography

Healthy controlls

Healthy indyviduals.

Diagnostic Test: Polysomnography

Interventions

Polysomnography DIAGNOSTIC_TEST

Each of the patients will undergo polysomnography

COMISA group; Healthy controlls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspicion of COMISA referred to the Department of Internal Medicine, Occupational Diseases, Hypertension and Clinical Oncology operating at the Wroclaw Medical University. Healthy controls.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, Poland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Bruxism; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Cardiovascular Diseases

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Helena Martynowicz, Associate professor

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: June 1, 2021
• Primary Completion: January 30, 2024
• Study Completion: March 30, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

PL (1)