跳至主要内容
临床试验/NCT07147803
NCT07147803进行中(未招募)不适用

Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis in Asyut University Hospitals: Correlation With Clinical, Functional, and Radiological Parameters

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
prevalence of poor sleep

研究概览

简要总结

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.

详细描述

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.

Our 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)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years (adults).
  • 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.
  • Non-cystic fibrosis etiology: no clinical diagnosis of cystic fibrosis; if prior doubt, a negative/normal sweat chloride or genetic report will be needed.

排除标准

  • Acute exacerbation at screening or within the preceding 4 weeks, or need for systemic antibiotics or systemic corticosteroids in that window.
  • Severe hemoptysis, unstable respiratory status, or any condition where completing questionnaires/testing is unsafe per investigator.
  • 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).

结局指标

主要结局

prevalence of poor sleep

时间窗: 24 hours

(PSQI \> 5)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Montaser Gamal Ahmed

Lecturer of Chest Diseases and Tuberculosis

Assiut University

研究点 (1)

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