Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis

NCT ID: NCT07147803

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-01-01

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.

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)

Conditions

Bronchiectasis; Sleep-Disordered Breathing

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Pittsburgh Sleep Quality Index

Intervention Type: OTHER

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

Interventions

Pittsburgh Sleep Quality Index

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

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Montaser Gamal Ahmed

Lecturer of Chest Diseases and Tuberculosis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Montaser Gamal, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University hospital

Asyut, Asyut Governorate, Egypt

Countries

Egypt

References

Gao Y, Guan W, Xu G, Lin Z, Tang Y, Lin Z, Li H, Gao Y, Luo Q, Zhong N, Chen R. Sleep disturbances and health-related quality of life in adults with steady-state bronchiectasis. PLoS One. 2014 Jul 18;9(7):e102970. doi: 10.1371/journal.pone.0102970. eCollection 2014.

Reference Type: BACKGROUND

PMID: 25036723 (View on PubMed)

Martinez-Garcia MA, Athanazio RA, Giron R, Maiz-Carro L, de la Rosa D, Olveira C, de Gracia J, Vendrell M, Prados-Sanchez C, Gramblicka G, Corso Pereira M, Lundgren FL, Fernandes De Figueiredo M, Arancibia F, Rached SZ. Predicting high risk of exacerbations in bronchiectasis: the E-FACED score. Int J Chron Obstruct Pulmon Dis. 2017 Jan 18;12:275-284. doi: 10.2147/COPD.S121943. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28182132 (View on PubMed)

Other Identifiers

MGAhmed-Sleep-Bronchiectasis

Identifier Type: -

Identifier Source: org_study_id