Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis

NCT07147803 | Active Not Recruiting DMC

• 1 other identifier: MGAhmed-Sleep-Bronchiectasis
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis; Sleep-Disordered Breathing

Keywords

Bronchiectasis; Sleep; Quality of life; Exacerbations

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (14)

• Change in Pittsburgh Sleep Quality Index Global Score From Baseline to Month 12

  Baseline, 3 months, 6 months, 9 months, and 12 months.

• Number of Bronchiectasis Exacerbations During 12-Month Follow-up

  Baseline to 12 months follow-up

• Time to First Bronchiectasis Exacerbation

  Baseline to 12 months follow-up

• Time to First Bronchiectasis-Related Hospital Admission

  Baseline to 12 months follow-up

• 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.

Other Outcomes (9)

• Change in Neutrophil-to-Lymphocyte Ratio From Baseline to Month 12

  Baseline, 3 months, 6 months, 9 months, and 12 months.

• Change in C-Reactive Protein From Baseline to Month 12

  Baseline, 3 months, 6 months, 9 months, and 12 months.

• Change in Hospital Anxiety and Depression Scale Scores From Baseline to Month 12

  Baseline, 3 months, 6 months, 9 months, and 12 months.

Study Arms (1)

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

Other: Pittsburgh Sleep Quality Index

Interventions

Pittsburgh Sleep Quality Index OTHER

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.

Bronchiectasis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, 71515, Egypt

Location

Related Publications (2)

• 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.

  PMID: 25036723 BACKGROUND

• 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.

  PMID: 28182132 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Montaser Gamal, Lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Chest Diseases and Tuberculosis

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: April 30, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)