Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 10:49 AM
Study NCT ID:
NCT05242406
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of EMST Systemic Inflammation and Oxidative Stress in Patients With Moderate OSAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-02-07', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease severity', 'timeFrame': '2 days', 'description': 'Polysomnography recordings will be taken especially sleep efficiency and apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity'}, {'measure': 'Oxidative stress-1', 'timeFrame': '5 days', 'description': 'TAS:Venous blood sample will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning after an overnight fast and will be analyzed with a colorimetric kit.'}, {'measure': 'Systemic inflammation-1', 'timeFrame': '5 days', 'description': 'CRP:biochemistry laboratory will work on the Abbott Architect C4000 (USA) clinical chemistry autoanalyzer.'}, {'measure': 'Systemic inflammation-2', 'timeFrame': '5 days', 'description': 'TNF-a:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit.'}, {'measure': 'Systemic inflammation-3', 'timeFrame': '5 days', 'description': 'IL10:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit.'}, {'measure': 'Systemic inflammation-4', 'timeFrame': '5 days', 'description': 'IL-6:After an overnight fast, venous blood samples will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning and analyzed with the ELISA kit.'}, {'measure': 'Oxidative stress-2', 'timeFrame': '5 days', 'description': 'TOS:Venous blood sample will be taken from the forearms of the patients in a 5 mL gel biochemistry tube with serum separator between 8.00-11.00 in the morning after an overnight fast and will be analyzed with a colorimetric kit.'}], 'secondaryOutcomes': [{'measure': 'Exercise capacity', 'timeFrame': '2 days', 'description': '6 minute walking testing (6MWT):The primary outcome is the distance covered in meters or converted measure (such as feet) over 6 minutes. To measure functional aerobic capacity or general fitness, this test may be used in conjunction with VO2 testing.'}, {'measure': 'Maximal inspiratory and expiratory muscle strength', 'timeFrame': '2 days', 'description': 'Maximal inspiratory and expiratory muscle strength will be evaluated with mouth pressure device.'}, {'measure': 'Daytime sleepiness', 'timeFrame': '2 days', 'description': "Epworth Sleepiness Scale . Minimum and maximum scores: 0-24. The higher Epworth Sleepiness Scale score means the higher that person's average sleep propensity in daily life , or their 'daytime sleepiness'"}, {'measure': 'Fatigue severity.', 'timeFrame': '2 days', 'description': 'Fatigue Severity Scale (FSS)Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception'}, {'measure': 'Sleep quality', 'timeFrame': '2 days', 'description': 'The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Oxidative Stress'], 'conditions': ['Obstructive Sleep Apnea', 'Oxidative Stress', 'Respiratory Muscle Training']}, 'referencesModule': {'references': [{'pmid': '39297486', 'type': 'DERIVED', 'citation': 'Erturk N, Celik A, Kahraman Yaman S, Yaman H, Unal F, Calik Kutukcu E. Expiratory muscle strength training reduces oxidative stress and systemic inflammation in men with obstructive sleep apnea syndrome: a double-blinded, randomized parallel trial. Sleep. 2024 Dec 11;47(12):zsae221. doi: 10.1093/sleep/zsae221.'}]}, 'descriptionModule': {'briefSummary': 'It was aimed to investigate the effect of expiratory muscle strength training (EMST) applied at different intensities on systemic inflammation and oxidative stress in patients with moderate obstructive sleep apnea syndrome (OSAS). In the study, 32 male patients diagnosed with moderate OSAS will be included in the study. Participants will then be divided into 2 groups by block randomization. In the three-blind planned study; the first group will receive high-intensity %60 maximum expiratory pressure (MEP) EMST training, and the second group will be given low-intensity 30% of MEP, EMST training for 12 weeks. Disease-related symptoms, disease severity apnea-hypopnea index (AHI), oxidative stress index (OSI) and systemic inflammation level, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and fatigue severity will be evaluated before and after the study.', 'detailedDescription': 'Primary outcome measures are; disease severity, oxidative stress index and systemic inflammation.\n\nSecondary outcome measurements are; disease-related symptoms, exercise capacity, respiratory muscle strength, sleep quality, daytime sleepiness, and severity of fatigue.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male patients diagnosed with moderate OSAS by polysomnography in the Sleep Center of Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital,\n2. Those who are between 19-60 years old,\n3. Stable general health status,\n4. Volunteer to participate in the research,\n5. Not using NIMV device,\n\n5\\) Patients who do not have a mental problem that will prevent cooperation will be included.\n\nExclusion Criteria:\n\n1. Female gender,\n2. Having a previous stroke,\n3. Having an overlap syndrome,\n4. Having any neurological, psychological or cardiac disease,\n5. Uncontrolled hypertension and high blood glucose levels,\n6. Severe obstructive nasal disease,\n7. History of previous oropharyngeal surgery\n8. Having a body mass index of 40 kg/m2 or more,\n9. Using drugs, alcohol, sedative and hypnotic drugs,\n10. Having a cognitive problem'}, 'identificationModule': {'nctId': 'NCT05242406', 'briefTitle': 'Effect of EMST Systemic Inflammation and Oxidative Stress in Patients With Moderate OSAS', 'organization': {'class': 'OTHER', 'fullName': 'Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital'}, 'officialTitle': 'Investigation of the Effect of Expiratory Muscle Strength Training Applied at Different Intensities on Systemic Inflammation and Oxidative Stress in Patients With Moderate Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': '2021/363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'H-EMST', 'description': 'In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 12 weeks will be trained with a 1-minute rest cycle in 5 breaths.\n\nPatients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 60% of the new measurement.', 'interventionNames': ['Other: Expiratory muscle trainig']}, {'type': 'EXPERIMENTAL', 'label': 'L-EMST', 'description': 'At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 12 weeks will be trained once a day with a 1-minute rest cycle in 5 breaths.\n\nPatients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 30% of the new measurement.', 'interventionNames': ['Other: Expiratory muscle trainig']}], 'interventions': [{'name': 'Expiratory muscle trainig', 'type': 'OTHER', 'description': 'This exercise will be used to strengthen forced expiratory muscles.', 'armGroupLabels': ['H-EMST', 'L-EMST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61100', 'city': 'Ortahi̇sar', 'state': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital'}], 'overallOfficials': [{'name': 'Adem Çelik, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital'}, {'name': 'Sevim Kahraman Yaman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital'}, {'name': 'Hüseyin Yaman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karadeniz Technical University'}, {'name': 'Nurel Erturk, MsC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital'}, {'name': 'Ebru Çalık Kütükçü, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'NUREL ERTURK', 'investigatorAffiliation': 'Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital'}}}}