Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT07184060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiographic Assessment of Pulmonary Hypertension in Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], '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'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-13', 'studyFirstSubmitDate': '2025-09-13', 'studyFirstSubmitQcDate': '2025-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Pulmonary Artery Pressure', 'timeFrame': 'baseline', 'description': 'The primary objective is to assess the presence and degree of pulmonary hypertension (measured by echocardiography) in OSA patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'pulmonary hypertension'], 'conditions': ['Obstructive Sleep Apnea (OSA)', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'This study investigates the association between obstructive sleep apnea (OSA) and pulmonary hypertension (PH), focusing on the relationship between OSA severity and pulmonary arterial pressures in adult patients.', 'detailedDescription': 'This prospective, observational, cross-sectional study will be conducted in the pulmonology and sleep medicine departments of Assiut University. Patients diagnosed with OSA through overnight polysomnography will be assessed for the presence and severity of PH using echocardiography. The study aims to determine whether OSA serves as an independent risk factor for PH and whether the severity of OSA, as measured by apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), correlates with echocardiographic indicators of PH. Data will be analyzed using standardized statistical methods to establish links between OSA severity and hemodynamic changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants are 18-65 years old and diagnosed with OSA (AHI ≥ 5 events/hour) confirmed through full-night polysomnographic sleep study. Patients will be stratified into mild (AHI 5-14), moderate (AHI 15-29), and severe OSA (AHI ≥ 30). Exclusion criteria include patients with secondary PH (from cardiac causes, chronic thromboembolic disease, or pulmonary conditions), chronic vasodilator therapy, long-term oxygen therapy, advanced organ failure, neuromuscular or chest wall deformities, obesity hypoventilation syndrome, or malignancy. The expected sample size is 55 patients, ensuring enough statistical power to detect associations. Demographic, clinical, echocardiographic, radiological, and sleep study parameters will be collected for each patient.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18-65 years\n\nDiagnosed with obstructive sleep apnea (OSA) by full-night polysomnography\n\nApnea-Hypopnea Index (AHI) ≥ 5 events/hour\n\nExclusion Criteria:\n\nSecondary pulmonary hypertension due to:Chronic pulmonary diseases, Left ventricular heart disease and Chronic thromboembolic disorders\n\nUse of pulmonary vasodilator therapy\n\nLong-term oxygen therapy (LTOT)\n\nRespiratory neuromuscular weakness\n\nChest wall deformities\n\nEnd-organ failure (cardiac, renal, hepatic)\n\nMalignancy\n\nObesity hypoventilation syndrome'}, 'identificationModule': {'nctId': 'NCT07184060', 'briefTitle': 'Echocardiographic Assessment of Pulmonary Hypertension in Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'A Prospective Observational Study on Pulmonary Hypertension in Patients With Obstructive Sleep Apnea: Correlation of Apnea-Hypopnea Severity With Pulmonary Artery Pressures', 'orgStudyIdInfo': {'id': 'Pulmonary Hypertension in OSA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adult patients with confirmed OSA', 'description': 'Eligible participants are 18-65 years old and diagnosed with OSA (AHI ≥ 5 events/hour) confirmed through full-night polysomnographic sleep study. Patients will be stratified into mild (AHI 5-14), moderate (AHI 15-29), and severe OSA (AHI ≥ 30). Exclusion criteria include patients with secondary PH (from cardiac causes, chronic thromboembolic disease, or pulmonary conditions), chronic vasodilator therapy, long-term oxygen therapy, advanced organ failure, neuromuscular or chest wall deformities, obesity hypoventilation syndrome, or malignancy. The expected sample size is 55 patients, ensuring enough statistical power to detect associations. Demographic, clinical, echocardiographic, radiological, and sleep study parameters will be collected for each patient.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at the of Chest Diseases department', 'investigatorFullName': 'Ashraqat Tony Badawy', 'investigatorAffiliation': 'Assiut University'}}}}