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Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis

StatusActive, Not Recruiting
PhaseNot specified
Started2025-04-30
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Assiut University

Amendment history

2026-09-25
critical
Primary endpoint(s) modified1 entry, revised
Wasprevalence of poor sleep
NowPrevalence of poor sleep quality
Final enrollment: 200 participants (planned 60)
Primary completion confirmed: October 2025 (last estimated December 2025)
Completion pushed: 2026-01-01 → 2026-11-01
2025-09-29
notable
Not Yet Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Start dateestimated 2025-09-01→confirmed 2025-09-30
Study sitesdetails revised at 1 of 1 site
2025-08-22
minor
Original filing
1,604 trials monitored
See 18 trials at risk
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. Participants are assessed at baseline and followed at 3, 6, 9, and 12 months to evaluate changes in sleep quality over time and their relationships with changes in clinical status, functional measures, quality of life, and subsequent bronchiectasis-related outcomes.
Trial Details
NCT Number NCT07147803
Lead Sponsor Assiut University
Conditions Bronchiectasis, Sleep-Disordered Breathing
Enrollment 200 participants
Start Date 2025-04-30
Primary Completion 2025-10-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-24