Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT07147803
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of poor sleep', 'timeFrame': '24 hours', 'description': '(PSQI \\> 5)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchiectasis', 'Sleep', 'Quality of life', 'Exacerbations'], 'conditions': ['Bronchiectasis', 'Sleep-Disordered Breathing']}, 'referencesModule': {'references': [{'pmid': '25036723', 'type': 'BACKGROUND', 'citation': 'Gao Y, Guan W, Xu G, Lin Z, Tang Y, Lin Z, Li H, Gao Y, Luo Q, Zhong N, Chen R. Sleep disturbances and health-related quality of life in adults with steady-state bronchiectasis. PLoS One. 2014 Jul 18;9(7):e102970. doi: 10.1371/journal.pone.0102970. eCollection 2014.'}, {'pmid': '28182132', 'type': 'BACKGROUND', 'citation': 'Martinez-Garcia MA, Athanazio RA, Giron R, Maiz-Carro L, de la Rosa D, Olveira C, de Gracia J, Vendrell M, Prados-Sanchez C, Gramblicka G, Corso Pereira M, Lundgren FL, Fernandes De Figueiredo M, Arancibia F, Rached SZ. Predicting high risk of exacerbations in bronchiectasis: the E-FACED score. Int J Chron Obstruct Pulmon Dis. 2017 Jan 18;12:275-284. doi: 10.2147/COPD.S121943. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Non-cystic fibrosis (non-CF) bronchiectasis is a chronic, heterogeneous airway disease characterized by irreversible bronchial dilatation, persistent airway infection, and neutrophilic inflammation that together drive daily cough, sputum production, recurrent exacerbations, and progressive functional decline. Sleep is a key determinant of Health-Related Quality of Life (HRQoL) and cardiometabolic health. In chronic lung diseases, nocturnal hypoxemia, cough, dyspnea, and systemic inflammation commonly disrupt sleep continuity and architecture. In bronchiectasis specifically, several studies show high rates of poor sleep quality using the Pittsburgh Sleep Quality Index (PSQI), with \\~50-60% of clinically stable patients classified as "poor sleepers," often accompanied by daytime dysfunction. Poor sleep correlates with disease severity indices and symptoms such as nocturnal cough.', 'detailedDescription': 'In Egypt, bronchiectasis is a frequent clinical problem seen across tertiary hospitals. Recent tertiary-center studies from Upper Egypt (including Asyut) have described the prevalence and early outcomes of bronchiectasis among admitted adults, underscoring its local clinical significance. However, despite multiple Egyptian works on sleep quality in other respiratory conditions (e.g., COPD) using the PSQI, there remains a clear evidence gap regarding sleep quality specifically in adult non-CF bronchiectasis. International cohorts consistently demonstrate prevalent sleep disturbance in bronchiectasis and links to clinical severity, but Egyptian data in non-CF adult bronchiectasis are scarce. Locally contextualized evidence is needed to understand whether sleep impairment in our patients aligns with international observations and how it relates to spirometric function, structural disease burden, composite severity indices, and inflammatory biomarkers within an Upper Egypt setting.\n\nOur study aims to Quantify sleep quality using the PSQI in adults with non-CF bronchiectasis attending Asyut University Hospitals, and Evaluate its correlations with clinical parameters (symptoms, exacerbations, mMRC, Quality of Life)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Age ≥18 years (adults).\n* Confirmed non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio \\>1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years (adults).\n* Confirmed non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio \\>1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record.\n* Non-cystic fibrosis etiology: no clinical diagnosis of cystic fibrosis; if prior doubt, a negative/normal sweat chloride or genetic report will be needed.\n\nExclusion Criteria:\n\n* Acute exacerbation at screening or within the preceding 4 weeks, or need for systemic antibiotics or systemic corticosteroids in that window.\n* Severe hemoptysis, unstable respiratory status, or any condition where completing questionnaires/testing is unsafe per investigator.\n* Primary sleep disorders that would cloud PSQI interpretation unless stable ≥3 months (e.g., moderate-severe OSA newly diagnosed and initiating PAP therapy; narcolepsy; untreated restless legs).'}, 'identificationModule': {'nctId': 'NCT07147803', 'briefTitle': 'Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis in Asyut University Hospitals: Correlation With Clinical, Functional, and Radiological Parameters', 'orgStudyIdInfo': {'id': 'MGAhmed-Sleep-Bronchiectasis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bronchiectasis Patients', 'description': 'Confirmed non-CF bronchiectasis on high-resolution CT (HRCT) by a chest radiologist, with standard features (e.g., broncho-arterial ratio \\>1, lack of tapering, airways visible within 1 cm of pleura), documented in the medical record', 'interventionNames': ['Other: Pittsburgh Sleep Quality Index']}], 'interventions': [{'name': 'Pittsburgh Sleep Quality Index', 'type': 'OTHER', 'description': 'PSQI (Arabic validated version) - main sleep measure; global score 0-21; PSQI \\>5 = poor sleep quality.', 'armGroupLabels': ['Bronchiectasis Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Assiut University hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Montaser Gamal, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Chest Diseases and Tuberculosis', 'investigatorFullName': 'Montaser Gamal Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}