Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis

NCT07147803 · tracked via the Priya Life Science Egypt tracker

Sponsor

Assiut University

Phase

Observational

Started

2025-04-30

Last updated

2026-09-24

Condition(s) studied

BronchiectasisSleep-Disordered Breathing

Investigational drug(s) / intervention(s)

Pittsburgh Sleep Quality Index

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Assiut University hospital	Asyut	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07147803 on ClinicalTrials.gov ↗ ← All trials in Egypt