Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis in Asyut University Hospitals: Correlation With Clinical, Functional, and Radiological Parameters
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Prevalence of poor sleep quality
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.
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.
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). Participants are also followed at 3, 6, 9, and 12 months to assess longitudinal changes in sleep quality and their relationships with changes in clinical and functional status, quality of life, and subsequent bronchiectasis-related outcomes.
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
- 否
入选标准
- •Age ≥18 years (adults).
- •Confirmed stable 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 is required.
- •Ability and willingness to participate in scheduled follow-up assessments at 3, 6, 9, and 12 months.
排除标准
- •Acute bronchiectasis exacerbation at screening or within the preceding 4 weeks, including treatment with systemic antibiotics and/or systemic corticosteroids for respiratory deterioration during that period.
- •Severe hemoptysis, unstable respiratory status, or any medical condition making completion of study questionnaires or scheduled assessments unsafe or unreliable in the investigator's judgment.
- •Primary sleep disorders likely to substantially confound interpretation of sleep-quality measures, including newly diagnosed moderate-to-severe obstructive sleep apnea initiating positive airway pressure therapy, narcolepsy, or untreated restless legs syndrome; patients with previously diagnosed sleep disorders on stable treatment for ≥3 months may be included.
- •Active pulmonary tuberculosis, interstitial lung disease, lung malignancy, pregnancy, or severe neurological or cognitive impairment that would prevent reliable completion of study assessments.
研究组 & 干预措施
Bronchiectasis Patients
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
干预措施: Pittsburgh Sleep Quality Index (Other)
结局指标
主要结局
Prevalence of poor sleep quality
时间窗: Baseline
Assessment of the proportion of participants with poor sleep quality using the validated Arabic version of the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Poor sleep quality is defined as a PSQI global score \>5. Unit of measure: percentage of participants with PSQI \>5.
prevalence of poor sleep
时间窗: 24 hours
(PSQI \> 5)
次要结局
- Change in Pittsburgh Sleep Quality Index Global Score From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Number of Bronchiectasis Exacerbations During 12-Month Follow-up(Baseline to 12 months follow-up)
- Time to First Bronchiectasis Exacerbation(Baseline to 12 months follow-up)
- Time to First Bronchiectasis-Related Hospital Admission(Baseline to 12 months follow-up)
- Change in Forced Expiratory Volume in One Second Percent Predicted From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in Forced Vital Capacity Percent Predicted From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in Modified Medical Research Council Dyspnea Score From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months)
- Change in Cough Severity Visual Analogue Scale From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in Six-Minute Walk Distance From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in Pittsburgh Sleep Quality Index Component Scores From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in Resting Peripheral Oxygen Saturation From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Change in Quality of Life-Bronchiectasis Domain Scores From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months.)
- Number of Bronchiectasis-Related Hospital Admissions During 12-Month Follow-up(Baseline to 12 months follow-up.)
- Change in FEV1/FVC Ratio From Baseline to Month 12(Baseline, 3 months, 6 months, 9 months, and 12 months)
研究者
Montaser Gamal Ahmed
Lecturer of Chest Diseases and Tuberculosis
Assiut University