Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-28 @ 9:55 AM
Study NCT ID:
NCT07027956
Status:
RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Function and Oxygenation in Smokers and Non-smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}], 'ancestors': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced vital capacity', 'timeFrame': '1st day', 'description': 'Forced vital capacity (FVC) will be assessed using spirometry.'}, {'measure': 'Forced expiratory volume in one second', 'timeFrame': '1st day', 'description': 'Forced expiratory volume in one second (FEV1) will be assessed using spirometry'}, {'measure': 'Forced expiratory volume in one second/forced vital capacity ratio', 'timeFrame': '1st day', 'description': 'Forced expiratory volume in one second/forced vital capacity ratio will be assessed using spirometry.'}, {'measure': 'Peak expiratory flow', 'timeFrame': '1st day', 'description': 'Peak expiratory flow (PEF) will be assessed using spirometry.'}, {'measure': 'Forced mid-expiratory flow', 'timeFrame': '1st day', 'description': 'Forced mid-expiratory flow (FEF25-75) will be assessed using spirometry.'}, {'measure': 'Inspiratory muscle strength', 'timeFrame': '1st day', 'description': 'Strength index will be evaluated.'}, {'measure': 'Exercise capacity', 'timeFrame': '2nd day', 'description': 'will be evaluated with 6 minute walk test and total distance will be recorded.'}, {'measure': 'Intercostal muscle oxygenation', 'timeFrame': '2nd day', 'description': 'During the 6-minute walking test, oxygenation of the intercostal muscles will be evaluated with a monitor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Smoking, Tobacco']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare respiratory function, exercise capacity, and intercostal muscle oxygenation in healthy smokers and non-smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with smokers and non-smokers will be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Smokers):\n\n* According to the World Health Organization and ICD smoking addiction criteria, consuming at least one cigarette every day for the last year\n* Volunteering to participate in research\n* Able to walk and cooperate\n\nExclusion Criteria (Smokers):\n\n* Having any cardiopulmonary disease\n* Having a musculoskeletal problem that could affect the tests\n* Failure to comply with tests\n\nInclusion Criteria (Non-smokers):\n\n* According to the World Health Organization and ICD smoking addiction criteria, having never smoked or not having smoked in the last year\n* Volunteering to participate in research\n* Able to walk and cooperate\n\nExclusion Criteria (Non-smokers):\n\n* Having any cardiopulmonary disease\n* Having a musculoskeletal problem that could affect the tests\n* Failure to comply with tests'}, 'identificationModule': {'nctId': 'NCT07027956', 'briefTitle': 'Respiratory Function and Oxygenation in Smokers and Non-smokers', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'A Comparison of Respiratory Function, Exercise Capacity and Oxygenation Between Smokers and Non-smokers', 'orgStudyIdInfo': {'id': '2025-08/88'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smokers'}, {'label': 'Non-smokers'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırşehir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merve Firat', 'role': 'CONTACT', 'email': 'mervefirat@ahievran.edu.tr', 'phone': '+90 850 441 02 44', 'phoneExt': '2490'}], 'facility': 'Kirsehir Ahi Evran University', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}], 'centralContacts': [{'name': 'Merve Firat', 'role': 'CONTACT', 'email': 'mervefirat@ahievran.edu.tr', 'phone': '+90 850 441 02 44', 'phoneExt': '2490'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Merve Firat', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}