Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2025-12-31 @ 10:13 PM
Study NCT ID:
NCT05719233
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2023-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2023-02-07', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive impairment', 'timeFrame': '1 MONTH', 'description': 'a 30-point test used to assess cognitive function; includes tests of orientation, attention, memory, language, and visual-spatial skills. MMSE score 24-30: no cognitive impairment, 19-23: mild cognitive impairment, 10-18: moderate cognitive impairment, ≤ 9: severe cognitive impairment'}, {'measure': 'Anxiety level', 'timeFrame': '1 MONTH', 'description': 'consists of 14 items and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where a score ≤ 17 indicates mild anxiety, 18-24 mild to moderate severity, and more than 24 moderate to severe anxiety'}, {'measure': 'Depression level', 'timeFrame': '1 MONTH', 'description': 'The original HAM-D has 21 items, but scoring is based only on the first 17. Scores less than or equal to 7 indicates normal response, 8-13 mild depression, 14-18 Moderate, 19-22 severe, and more than 22 very severe depression'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interstitial lung disease', 'cognitive function', 'spirometry', 'anxiety'], 'conditions': ['Lung Diseases, Interstitial']}, 'referencesModule': {'references': [{'pmid': '18938666', 'type': 'BACKGROUND', 'citation': 'Antonelli-Incalzi R, Corsonello A, Trojano L, Acanfora D, Spada A, Izzo O, Rengo F. Correlation between cognitive impairment and dependence in hypoxemic COPD. J Clin Exp Neuropsychol. 2008 Feb;30(2):141-50. doi: 10.1080/13803390701287390.'}, {'pmid': '17673067', 'type': 'BACKGROUND', 'citation': 'Ryu JH, Daniels CE, Hartman TE, Yi ES. Diagnosis of interstitial lung diseases. Mayo Clin Proc. 2007 Aug;82(8):976-86. doi: 10.4065/82.8.976.'}, {'pmid': '26374298', 'type': 'BACKGROUND', 'citation': 'Bors M, Tomic R, Perlman DM, Kim HJ, Whelan TP. Cognitive function in idiopathic pulmonary fibrosis. Chron Respir Dis. 2015 Nov;12(4):365-72. doi: 10.1177/1479972315603552. Epub 2015 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain. Early detection and accurate management of comorbidity have benefits in reducing ILD morbidity and mortality.', 'detailedDescription': 'Research on the impact of lung diseases on neuropsychological functioning has revealed impaired cognitive processing in patients with a variety of pulmonary disorders. While the mechanisms responsible for the association of pulmonary diseases and neurocognitive functioning remain unclear, some researchers have attributed it to reduced oxygenation of the brain.\n\nInterstitial Lung Disease (ILD) is an "umbrella" term as it comprises a variety of pulmonary diseases which affect the interstitium (the tissue and space around the air sacs of the lungs). It may be caused by a variety of factors (namely, inhaled substances, medications, infection, connective tissue disease, malignancy or idiopathic reasons) and has a clear negative impact on patients\' quality of life, leading to symptoms such as fatigue, dyspnea and coughing. Physical sequelae include reduced lung volumes due to tissue thickening, sometimes caused by inflammation. A further consequence is reduced breathing efficiency, resulting in reduced blood oxygen levels and compromised exercise capacity.\n\nAdditionally, the fibrosis of the parenchyma impedes the level of gas exchange. A number of studies have reported mood effects in ILD, suggesting, however, that the diagnosis of depression may be obscured, due to the fatigue and apathy that is often a consequence of ILD.\n\nEarly detection and accurate management of Neuropsychiatric comorbidities have benefits in reducing ILD morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis either visiting out patient clinic or admitted to ward in assiut university hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Interstitial lung disease patients diagnosed using high resolution computed tomography to confirm the diagnosis\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study.\n* Age less than 18,\n* A history of neurological and/or developmental disorders and related drug treatment,\n* A head injury with loss of consciousness,\n* Active alcohol or drug abuse or a history of abuse prior to testing,\n* A history of any psychiatric disorder or treatment, neurological disorders, psychological disorders, dementia, Alzheimer's disease, end-organ failure conditions"}, 'identificationModule': {'nctId': 'NCT05719233', 'briefTitle': 'Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease', 'orgStudyIdInfo': {'id': 'Neuropsychiatric Sequel of ILD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interstitial Lung disease Group', 'description': 'Mini-mental state examination (MMSE) Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale Nerve conduction studies High resolution Chest Computed tomography Pulmonary function Test'}, {'label': 'Control Group', 'description': 'Mini-mental state examination (MMSE) Hamilton Anxiety Rating Scale Hamilton Depression Rating Scale Nerve conduction studies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Waleed Gamal Elddin Khaleel, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut university, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of chest diseases and tuberculosis', 'investigatorFullName': 'Waleed Gamal Elddin Khaleel', 'investigatorAffiliation': 'Assiut University'}}}}