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Active, Not Recruiting

NCT Number: NCT07147803

Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 71515, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Pittsburgh Sleep Quality Index

Other

PSQI (Arabic validated version) - main sleep measure; global score 0-21; PSQI >5 = poor sleep quality.

Primary outcomes

  1. prevalence of poor sleep

    Time frame: 24 hours

    (PSQI > 5)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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