Bronchiectasis, Sleep-Disordered Breathing
Conditions
Keywords
Bronchiectasis, Sleep, Quality of life, Exacerbations
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Assiut University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of poor sleep quality | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cough Severity Visual Analogue Scale From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months. | 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. |
| Change in Six-Minute Walk Distance From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months. | 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. |
| Change in Pittsburgh Sleep Quality Index Component Scores From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months. | 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. |
| Change in Resting Peripheral Oxygen Saturation From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months. | 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. |
| Change in Quality of Life-Bronchiectasis Domain Scores From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months. | 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. |
| Number of Bronchiectasis-Related Hospital Admissions During 12-Month Follow-up | Baseline to 12 months 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. |
| Change in FEV1/FVC Ratio From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months | 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. |
| Change in Pittsburgh Sleep Quality Index Global Score From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months. | 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. |
| Number of Bronchiectasis Exacerbations During 12-Month Follow-up | Baseline to 12 months 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 to First Bronchiectasis Exacerbation | Baseline to 12 months follow-up | 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 to First Bronchiectasis-Related Hospital Admission | Baseline to 12 months follow-up | 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. |
| 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. | 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. |
| Change in Modified Medical Research Council Dyspnea Score From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months | 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. |
| Change in Forced Vital Capacity Percent Predicted From Baseline to Month 12 | Baseline, 3 months, 6 months, 9 months, and 12 months. | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMontaser Gamal, Lecturer
Assiut University
Outcome results
None listed