An observational study in Bronchiectasis and Sleep-Disordered Breathing, sponsored by Assiut University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Assiut University · Observational
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.
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.
368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's enrollment of 200 is above the median of 160 across 132 observational studies indexed under Bronchiectasis.
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Exclusion Criteria:
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
Other: Pittsburgh Sleep Quality Index
PSQI (Arabic validated version) - main sleep measure; global score 0-21; PSQI \>5 = poor sleep quality; assessed at baseline and during scheduled follow-up visits.
Prevalence of poor sleep quality
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.
Time frame: Baseline
Change in Pittsburgh Sleep Quality Index Global Score From Baseline to Month 12
Assessment of change in PSQI global score from baseline through scheduled follow-up visits at Months 3, 6, 9, and 12. The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Unit of measure: PSQI score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Number of Bronchiectasis Exacerbations During 12-Month Follow-up
Assessment of the number of clinically documented bronchiectasis exacerbations occurring during follow-up. Exacerbation frequency will be recorded for each participant over the 12-month observation period. Unit of measure: number of exacerbations per participant.
Time frame: Baseline to 12 months follow-up
Time to First Bronchiectasis Exacerbation
Assessment of time from baseline to the first clinically documented bronchiectasis exacerbation during follow-up. Longer time to first exacerbation indicates a longer exacerbation-free interval. Unit of measure: days.
Time frame: Baseline to 12 months follow-up
Time to First Bronchiectasis-Related Hospital Admission
Assessment of time from baseline to the first hospital admission attributable to bronchiectasis exacerbation or respiratory deterioration during follow-up. Longer time to first bronchiectasis-related hospitalization indicates a longer hospitalization-free interval. Unit of measure: days.
Time frame: Baseline to 12 months follow-up
Change in Forced Expiratory Volume in One Second Percent Predicted From Baseline to Month 12
Assessment of change in forced expiratory volume in one second percent predicted (FEV1% predicted) from baseline through Month 12. Greater preservation or improvement in FEV1% predicted indicates better pulmonary functional status. Unit of measure: percentage points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Forced Vital Capacity Percent Predicted From Baseline to Month 12
Assessment of longitudinal change in forced vital capacity percent predicted (FVC% predicted). Greater preservation or improvement indicates better pulmonary functional status. Unit of measure: percentage points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Modified Medical Research Council Dyspnea Score From Baseline to Month 12
Assessment of longitudinal change in dyspnea severity using the modified Medical Research Council (mMRC) scale. Scores range from 0 to 4, with higher scores indicating greater dyspnea-related functional limitation. Unit of measure: mMRC score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Change in Cough Severity Visual Analogue Scale From Baseline to Month 12
Assessment of longitudinal change in cough severity using a 0-10 visual analogue scale. Higher scores indicate greater cough severity. Unit of measure: VAS score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Six-Minute Walk Distance From Baseline to Month 12
Assessment of longitudinal change in functional exercise capacity using the six-minute walk test. Greater walking distance indicates better exercise capacity. Unit of measure: meters.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Pittsburgh Sleep Quality Index Component Scores From Baseline to Month 12
Assessment of longitudinal change in the seven PSQI component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component ranges from 0 to 3, with higher scores indicating greater impairment. Unit of measure: PSQI component score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Resting Peripheral Oxygen Saturation From Baseline to Month 12
Assessment of longitudinal change in resting peripheral oxygen saturation measured by pulse oximetry during clinical stability. Higher values indicate better resting oxygenation. Unit of measure: percentage points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Quality of Life-Bronchiectasis Domain Scores From Baseline to Month 12
Assessment of longitudinal change in Quality of Life-Bronchiectasis (QoL-B) domain scores during scheduled follow-up. QoL-B domains are scored from 0 to 100, with higher scores indicating better bronchiectasis-related health status and quality of life. Unit of measure: QoL-B domain score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Number of Bronchiectasis-Related Hospital Admissions During 12-Month Follow-up
Assessment of the number of hospital admissions attributable to bronchiectasis exacerbation or respiratory deterioration during follow-up. Unit of measure: number of hospital admissions per participant.
Time frame: Baseline to 12 months follow-up.
Change in FEV1/FVC Ratio From Baseline to Month 12
Assessment of longitudinal change in the ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) during scheduled follow-up. Higher values generally indicate less airflow obstruction. Unit of measure: percentage points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Change in Neutrophil-to-Lymphocyte Ratio From Baseline to Month 12
Assessment of change in peripheral blood neutrophil-to-lymphocyte ratio (NLR) during scheduled follow-up. Higher NLR values indicate greater systemic inflammatory burden. Unit of measure: ratio.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in C-Reactive Protein From Baseline to Month 12
Assessment of change in serum C-reactive protein concentration during scheduled follow-up. Higher concentrations indicate greater systemic inflammatory activity. Unit of measure: mg/L.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Hospital Anxiety and Depression Scale Scores From Baseline to Month 12
Assessment of longitudinal change in Hospital Anxiety and Depression Scale anxiety and depression subscale scores. Each subscale ranges from 0 to 21, with higher scores indicating greater psychological symptom burden. Unit of measure: HADS subscale score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Epworth Sleepiness Scale Score From Baseline to Month 12
Assessment of change in daytime sleepiness using the Epworth Sleepiness Scale (ESS). Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. Unit of measure: ESS score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Nocturnal Respiratory Symptom Burden From Baseline to Month 12
Assessment of longitudinal change in nocturnal respiratory symptom burden using the number of recorded nocturnal respiratory symptoms present, including cough, sputum production, wheeze, dyspnea, and respiratory-symptom-related sleep interruption. Higher values indicate greater nocturnal respiratory symptom burden. Unit of measure: symptom count (0-5).
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Association of Baseline Bronchiectasis Severity and Radiological Disease Burden With Longitudinal Sleep Outcomes
Assessment of baseline bronchiectasis severity using BSI, E-FACED, Modified Reiff score, number of involved lobes, bilateral disease, and predominant radiological morphology in relation to longitudinal sleep outcomes. Units of measure: score points, number of lobes, and categorical radiological characteristics, as applicable.
Time frame: Baseline characteristics assessed in relation to outcomes through 12 months follow-up
Change in Daily Sputum Burden From Baseline to Month 12
Assessment of longitudinal change in daily sputum burden, including sputum volume and recorded sputum characteristics where available. Greater sputum burden indicates greater respiratory symptom burden. Unit of measure: sputum volume category and/or mL per day, with sputum characteristics recorded categorically.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in Bronchiectasis Severity Scores From Baseline to Month 12
Assessment of longitudinal change in bronchiectasis severity using the Bronchiectasis Severity Index (BSI) and E-FACED score where recalculated during scheduled follow-up. Higher scores indicate greater disease severity. Unit of measure: BSI and E-FACED score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Change in STOP-BANG Score From Baseline to Month 12
Assessment of longitudinal change in obstructive sleep apnea risk using the STOP-BANG questionnaire. Scores range from 0 to 8, with higher scores indicating greater risk of obstructive sleep apnea. Unit of measure: STOP-BANG score points.
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months.
Plan to share: No
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Assiut University