- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07133035
- Original Trial
Investigation of Respiratory Function in Bruxism
August 19, 2025 updated by: Seval Yilmaz, Atılım University
Investigation of Respiratory Function, Biomechanical Properties of Neck and Jaw Muscles and Pain Sensitivity in Individuals With Bruxism
The aim of the study was to evaluate the respiratory functions, sleep quality and headache severity of individuals with bruxism and to compare them with the control group without bruxism.
Study Overview
Status
Active, not recruiting
Detailed Description
Bruxism is defined as a repetitive jaw muscle activity characterized by teeth grinding or clenching accompanied by tooth wear and jaw muscle discomfort in the absence of a medical condition.
Bruxism can occur during the day or during sleep and is defined as awake bruxism or sleep bruxism, respectively.
According to the diagnostic criteria of the American Sleep Disorders Association (AASM), the New Classification of Sleep Disorders (ICSD-3), sleep bruxism requires the presence of a regular or frequent teeth grinding sound during sleep, accompanied by at least one of the following symptoms: signs of tooth wear, morning jaw fatigue or pain, and/or temporal headache and/or jaw locking.
The etiology of bruxism is not fully understood but is influenced by psychosocial factors such as personality traits and stress.
Sleep bruxism has been defined as a sleep-related movement disorder and has been reported to be associated with other sleep disorders.
One sleep disorder reported to accompany bruxism is obstructive sleep apnea syndrome.
Obstructive sleep apnea syndrome (OSAS) is characterized by upper airway obstruction that disrupts normal sleep patterns and ventilation despite respiratory efforts.
OSAS is considered a risk factor for triggering bruxism.
It has been suggested that rhythmic masticatory muscle activity during sleep bruxism plays a role in lubricating the upper gastrointestinal tract and increasing airway patency.
This is assumed to facilitate better breathing.
The possible relationship between sleep bruxism and sleep apnea suggests that the respiratory functions of individuals with bruxism may differ from those of individuals without bruxism.
This difference is anticipated to be particularly pronounced in the supine sleep position.
A review of the literature revealed no studies evaluating the respiratory functions of individuals with sleep bruxism.
The study will also investigate sleep quality and headache severity in individuals with bruxism.
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gölbaşı
-
Ankara, Gölbaşı, Turkey, 06830
- Atılım University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Male and female individuals between the ages of 18-45
Description
Inclusion Criteria:
- Being between 18-45 years old
Exclusion Criteria:
Receiving orthodontic or splint treatment
- Having more than two missing teeth
- Having undergone jaw, thoracic, or abdominal surgery within the last 6 months
- Having a history of cervical and/or thoracic trauma
- Having a neurological, systemic, and/or cardiopulmonary disease
- Using sleeping pills
- Having a diagnosis of psychiatric illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Bruxism
Individuals diagnosed with bruxism
|
Participants' respiratory functions will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer (11).
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), the ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC), and peak expiratory flow rate (PEF) will be determined during the pulmonary function test.
The questionnaire consists of 10 questions covering headaches, neck pain, temporomandibular joint pain, pain during chewing, parafunctional habits, malocclusion, and stress, and is scored as 10 (yes), 5 (sometimes), and 0 (no).
The total score ranges from 0 to 100.
A higher total score indicates an increased risk of temporomandibular joint problems.
The Jennkis Sleep Scale consists of four questions that assess sleep problems over a 4-week period.
Each question is scored from 0 to 5. The total score ranges from 0 to 20 and indicates increasing sleep disturbance.
Berlin Questionnaire: The Berlin Questionnaire is a three-part assessment tool that assesses individuals' predisposition to sleep apnea.
The first part contains five questions investigating snoring, the second part contains four questions investigating daytime sleepiness, and the third part contains two questions investigating hypertension and obesity.
Each section is evaluated independently.
Individuals who score 2 or higher in the first and second sections, and those who score 1 in the third section, are considered predisposed to sleep apnea.
If two or more categories are positive, the participant is considered high risk for obstructive sleep apnea.
If the participant scores two or more in the first and second categories, they are considered high risk.
If blood pressure is high or BMI is above 30 kg/m2, the participant is considered high risk.
Headache Impact Test-6: The Headache Impact Test-6 (HIT-6) is administered to identify activities individuals are unable to perform due to headaches and to determine the extent to which headaches impact daily life.
This six-question questionnaire includes columns with increasing scores, from "never" to "always."
Participants are asked to mark the box closest to their response.
A high total score indicates that headaches negatively impact daily life.
|
|
Control
healthy individuals
|
Participants' respiratory functions will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer (11).
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), the ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC), and peak expiratory flow rate (PEF) will be determined during the pulmonary function test.
The questionnaire consists of 10 questions covering headaches, neck pain, temporomandibular joint pain, pain during chewing, parafunctional habits, malocclusion, and stress, and is scored as 10 (yes), 5 (sometimes), and 0 (no).
The total score ranges from 0 to 100.
A higher total score indicates an increased risk of temporomandibular joint problems.
The Jennkis Sleep Scale consists of four questions that assess sleep problems over a 4-week period.
Each question is scored from 0 to 5. The total score ranges from 0 to 20 and indicates increasing sleep disturbance.
Berlin Questionnaire: The Berlin Questionnaire is a three-part assessment tool that assesses individuals' predisposition to sleep apnea.
The first part contains five questions investigating snoring, the second part contains four questions investigating daytime sleepiness, and the third part contains two questions investigating hypertension and obesity.
Each section is evaluated independently.
Individuals who score 2 or higher in the first and second sections, and those who score 1 in the third section, are considered predisposed to sleep apnea.
If two or more categories are positive, the participant is considered high risk for obstructive sleep apnea.
If the participant scores two or more in the first and second categories, they are considered high risk.
If blood pressure is high or BMI is above 30 kg/m2, the participant is considered high risk.
Headache Impact Test-6: The Headache Impact Test-6 (HIT-6) is administered to identify activities individuals are unable to perform due to headaches and to determine the extent to which headaches impact daily life.
This six-question questionnaire includes columns with increasing scores, from "never" to "always."
Participants are asked to mark the box closest to their response.
A high total score indicates that headaches negatively impact daily life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced vital capacity (FVC)
Time Frame: From enrollment to the end of the assessment period at 2 hours
|
Participant's forced vital capacity (FVC) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer.
Forced vital capacity (FVC) is a subparameter of pulmonary function tests.
|
From enrollment to the end of the assessment period at 2 hours
|
|
Forced expiratory volume in one second (FEV1)
Time Frame: From enrollment to the end of the assessment period at 2 hours
|
Participants' forced expiratory volume in one second (FEV1) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer.
Forced forced expiratory volume in one second (FEV1) is a subparameter of pulmonary function tests.
|
From enrollment to the end of the assessment period at 2 hours
|
|
Peak expiratory flow rate (PEF)
Time Frame: From enrollment to the end of the assessment period at 2 hours
|
Peak expiratory flow rate (PEF) will be assessed in different positions with the Cosmed Pony Fx Digital Spirometer.
Peak expiratory flow rate (PEF) a subparameter of pulmonary function tests.
|
From enrollment to the end of the assessment period at 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seval Yılmaz, PhD., Atılım University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2024
Primary Completion (Estimated)
August 31, 2025
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
August 12, 2025
First Submitted That Met QC Criteria
August 19, 2025
First Posted (Actual)
August 20, 2025
Study Record Updates
Last Update Posted (Actual)
August 20, 2025
Last Update Submitted That Met QC Criteria
August 19, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6040102284-Bruxism
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are currently no plans to share the data and it is collected for internal use only
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Mahidol UniversityRamathibodi HospitalNot yet recruitingSleep Inertia | Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization | Night Shift WorkThailand
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Universidade Federal de PernambucoEnrolling by invitationSleep | Obstructive Sleep Apnea (OSA)Brazil
-
Atlas UniversityCompletedSleep | Surgery | Sleep QualityTurkey (Türkiye)
-
Mersin UniversityCompletedSleep Quality | Sleep PerceptionTurkey (Türkiye)
-
Hospital Felicio RochoNot yet recruitingSleep Apnea/Hypopnea Syndrome | Sleep Apnea Syndrome, Obstructive | Sleep Apnea Syndrome (OSAS) | Sleep Apnea - Obstructive
-
Brigham and Women's HospitalNot yet recruitingObstructive Sleep Apnea | Sleep-disordered BreathingUnited States
Clinical Trials on Pulmonary function test
-
Ankara City Hospital BilkentCompletedAnesthesia | Adolescent Idiopathic Scoliosis | Pulmonary Function Test, PreoperativeTurkey
-
Poitiers University HospitalCompletedRespiratory Insufficiency | Systemic Sclerosis | Pulmonary Function Test | Diaphragm Defect | Muscular Weakness | Diaphragmatic ElectromyographyFrance
-
Assiut UniversityUnknown
-
University Hospital, MontpellierUnknownFood Allergy Suspected | Food Allergy ProvedFrance
-
State University of New York - Upstate Medical...Mitsubishi Tanabe Pharma America Inc.Enrolling by invitation
-
AstraZenecaNot yet recruiting
-
Centre Hospitalier Universitaire Saint PierreRecruiting
-
Assiut UniversityCompletedPulmonary Hypertension | Interstitial Lung DiseaseEgypt
-
Hopital FochCompleted
-
Medical University InnsbruckBoehringer IngelheimRecruitingConnective Tissue Diseases | Systemic Sclerosis | Interstitial Lung DiseaseAustria