Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-29 @ 6:06 AM
Study NCT ID:
NCT07133035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Respiratory Function in Bruxism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002012', 'term': 'Bruxism'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced vital capacity (FVC)', 'timeFrame': 'From enrollment to the end of the assessment period at 2 hours', 'description': "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."}, {'measure': 'Forced expiratory volume in one second (FEV1)', 'timeFrame': 'From enrollment to the end of the assessment period at 2 hours', 'description': "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."}, {'measure': 'Peak expiratory flow rate (PEF)', 'timeFrame': 'From enrollment to the end of the assessment period at 2 hours', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bruxism', 'sleep', 'respiratory function', 'headache'], 'conditions': ['Bruxism', 'Sleep']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female individuals between the ages of 18-45', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18-45 years old\n\nExclusion Criteria:\n\n* Receiving orthodontic or splint treatment\n\n * Having more than two missing teeth\n * Having undergone jaw, thoracic, or abdominal surgery within the last 6 months\n * Having a history of cervical and/or thoracic trauma\n * Having a neurological, systemic, and/or cardiopulmonary disease\n * Using sleeping pills\n * Having a diagnosis of psychiatric illness'}, 'identificationModule': {'nctId': 'NCT07133035', 'briefTitle': 'Investigation of Respiratory Function in Bruxism', 'organization': {'class': 'OTHER', 'fullName': 'Atılım University'}, 'officialTitle': 'Investigation of Respiratory Function, Biomechanical Properties of Neck and Jaw Muscles and Pain Sensitivity in Individuals With Bruxism', 'orgStudyIdInfo': {'id': '6040102284-Bruxism'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bruxism', 'description': 'Individuals diagnosed with bruxism', 'interventionNames': ['Diagnostic Test: Pulmonary function test', 'Diagnostic Test: Fonseca Anamnestic Index', 'Other: Jenkins Sleep Scale', 'Other: Berlin Questionnaire', 'Other: Headache Impact Test-6']}, {'label': 'Control', 'description': 'healthy individuals', 'interventionNames': ['Diagnostic Test: Pulmonary function test', 'Diagnostic Test: Fonseca Anamnestic Index', 'Other: Jenkins Sleep Scale', 'Other: Berlin Questionnaire', 'Other: Headache Impact Test-6']}], 'interventions': [{'name': 'Pulmonary function test', 'type': 'DIAGNOSTIC_TEST', 'description': "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.", 'armGroupLabels': ['Bruxism', 'Control']}, {'name': 'Fonseca Anamnestic Index', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Bruxism', 'Control']}, {'name': 'Jenkins Sleep Scale', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Bruxism', 'Control']}, {'name': 'Berlin Questionnaire', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Bruxism', 'Control']}, {'name': 'Headache Impact Test-6', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Bruxism', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06830', 'city': 'Ankara', 'state': 'Gölbaşı', 'country': 'Turkey (Türkiye)', 'facility': 'Atılım University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Seval Yılmaz, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atılım University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are currently no plans to share the data and it is collected for internal use only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atılım University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Seval Yilmaz', 'investigatorAffiliation': 'Atılım University'}}}}