NCT03083405

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

ENROLLING BY INVITATION Last updated 4 March 2026

What this trial tests

trial testing Opipramol in Sleep Bruxism in 100 participants. Enrolling by invitation.

Timeline

20 April 2017

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	Wroclaw Medical University
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	100
Start date	20 April 2017
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	1 location across Poland

Drugs / interventions tested

• Opipramol (OPIPRAMOL) — full drug profile →

Conditions studied

• Sleep Bruxism — all drugs for Sleep Bruxism →
• Hypertension — all drugs for Hypertension →
• Thyroid Dysfunction — all drugs for Thyroid Dysfunction →
• Mental Status Change — all drugs for Mental Status Change →

Sponsor

Wroclaw Medical University

Who can join

Adults 18 to 70, any sex, with Sleep Bruxism or Hypertension. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Relationship between bruxism and quality of sleep assessed by polysomnography.
  Time frame: 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.

Sponsor's own 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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Genetic basis of sleep bruxism and sleep apnea-response to a medical puzzle.
   Wieckiewicz M, Bogunia-Kubik K, Mazur G, Danel D, et al · · 2020 · cited 85× · PMID 32367059 · DOI 10.1038/s41598-020-64615-y
2. The Relationship between Sleep Bruxism and Obstructive Sleep Apnea Based on Polysomnographic Findings.
   Martynowicz H, Gac P, Brzecka A, Poreba R, et al · · 2019 · cited 76× · PMID 31614526 · DOI 10.3390/jcm8101653
3. Sleep Bruxism and Occurrence of Temporomandibular Disorders-Related Pain: A Polysomnographic Study.
   Smardz J, Martynowicz H, Michalek-Zrabkowska M, Wojakowska A, et al · · 2019 · cited 46× · PMID 30915015 · DOI 10.3389/fneur.2019.00168
4. Correlation between Sleep Bruxism, Stress, and Depression-A Polysomnographic Study.
   Smardz J, Martynowicz H, Wojakowska A, Michalek-Zrabkowska M, et al · · 2019 · cited 44× · PMID 31470624 · DOI 10.3390/jcm8091344
5. The meaning of the masticatory muscle tonic-type electromyographic pathway correlated with sleep bruxism and sleep-related breathing disorders - A polysomnographic study.
   Smardz J, Martynowicz H, Wojakowska A, Michalek-Zrabkowska M, et al · · 2020 · cited 36× · PMID 32035303 · DOI 10.1016/j.sleep.2019.08.025
6. Determination of Inflammatory Markers, Hormonal Disturbances, and Sleepiness Associated with Sleep Bruxism Among Adults.
   Michalek-Zrabkowska M, Wieckiewicz M, Smardz J, Gac P, et al · · 2020 · cited 32× · PMID 33204200 · DOI 10.2147/nss.s268470
7. The effect of continuous positive airway pressure and mandibular advancement device on sleep bruxism intensity in obstructive sleep apnea patients.
   Martynowicz H, Wieczorek T, Macek P, Wojakowska A, et al · · 2022 · cited 25× · PMID 35512250 · DOI 10.1177/14799731211052301
8. Evaluation of Relationship Between Sleep Bruxism and Headache Impact Test-6 (HIT-6) Scores: A Polysomnographic Study.
   Martynowicz H, Smardz J, Michalek-Zrabkowska M, Gac P, et al · · 2019 · cited 25× · PMID 31139138 · DOI 10.3389/fneur.2019.00487