Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-05 @ 9:33 AM
Study NCT ID:
NCT06503757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-16
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ILD In Obese Patients With OSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prevalence of misinterpretation of interstitial lung disease (ILD) on high-resolution computed tomography (HRCT) scans in obese patients with obstructive sleep apnea (OSA).', 'timeFrame': 'Baseline', 'description': "determined by assessing the agreement between radiologists' interpretations of HRCT findings related to ILD in this specific patient population."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ILD']}, 'referencesModule': {'references': [{'pmid': '33561604', 'type': 'BACKGROUND', 'citation': 'Khor YH, Ryerson CJ, Landry SA, Howard ME, Churchward TJ, Edwards BA, Hamilton GS, Joosten SA. Interstitial lung disease and obstructive sleep apnea. Sleep Med Rev. 2021 Aug;58:101442. doi: 10.1016/j.smrv.2021.101442. Epub 2021 Jan 22.'}, {'pmid': '32701670', 'type': 'BACKGROUND', 'citation': 'Schiza SE, Bouloukaki I, Bolaki M, Antoniou KM. Obstructive sleep apnea in pulmonary fibrosis. Curr Opin Pulm Med. 2020 Sep;26(5):443-448. doi: 10.1097/MCP.0000000000000697.'}]}, 'descriptionModule': {'briefSummary': 'Assess the impact of obesity and OSA on the interpretation of high-resolution computed tomography (HRCT) findings in patients with ILD.\n\nIdentify specific challenges or confounding factors that may contribute to the misinterpretation of HRCT findings in this population.\n\nEvaluate the potential consequences of misinterpretation, including delayed or inaccurate diagnosis, inappropriate treatment decisions, and suboptimal patient outcomes.', 'detailedDescription': 'Obesity and obstructive sleep apnea (OSA) can lead to radiographic findings on HRCT that may be mistaken for interstitial lung disease (ILD) The increased adipose tissue deposition and altered lung mechanics associated with obesity, as well as the chronic intermittent hypoxia seen in OSA, can result in HRCT changes such as ground-glass opacities, septal thickening, and reduced lung volumes .\n\nSeveral studies have highlighted the potential for misdiagnosis of ILD in obese patients with OSA. A retrospective analysis by Washko et al. found that 32% of obese individuals with suspected ILD were subsequently reclassified as having changes related to obesity and OSA rather than true interstitial lung disease Similarly, a study by Patel et al. reported that 27% of patients referred for evaluation of suspected ILD were found to have findings attributable to obesity and OSA rather than an underlying interstitial lung process\n\nThe accurate differentiation between ILD and the HRCT changes associated with obesity and OSA is crucial, as the management strategies for these conditions differ significantly. Misdiagnosis can lead to unnecessary and potentially harmful treatments, as well as delayed recognition and management of the underlying obesity and OSA .\n\nTherefore, a comprehensive clinical evaluation, including assessment of body mass index, sleep study findings, and consideration of the full clinical context, is essential to correctly distinguish between ILD and the radiographic changes seen in obese patients with OSA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'collect relevant demographic and clinical data, including age, gender, BMI, OSA severity, ILD subtype (if available), pulmonary function test results, and details of previous treatments.\n\n2\\. HRCT Scans: HRCT images of the selected patients will be retrieved from the Picture Archiving and Communication System (PACS) or electronic medical record system.\n\n1\\. Radiological Assessment: will independently review the HRCT scans. They will assess the presence and extent of ILD, evaluate the specific radiological patterns (e.g., ground-glass opacities, reticular opacities, honeycombing), and record any other notable findings.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of obesity, defined by body mass index (BMI) ≥30 kg/m².\n* Confirmed diagnosis of OSA based on polysomnography\n* Availability of HRCT scans for analysis\n\nExclusion Criteria:\n\n* OSA in non obese patients\n* History of lung surgery or lung transplantation.'}, 'identificationModule': {'nctId': 'NCT06503757', 'briefTitle': 'ILD In Obese Patients With OSA', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Misinterpretation of ILD In Obese Patients With OSA', 'orgStudyIdInfo': {'id': 'ILD &OSA'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hend Mohamed Sayed Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}