NCT07175246

Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Systemic sclerosis (SSc) is a chronic autoimmune connective tissue disease characterized by progressive fibrosis of the skin and internal organs. Fatigue, non-restorative sleep, and poor sleep quality are frequently reported among patients with SSc, yet these symptoms remain under-recognized and under-investigated in clinical practice. Despite growing awareness of the burden of sleep-related symptoms, there is a significant lack of objective data regarding sleep disturbances in this population, particularly those assessed using polysomnography (PSG).

Detailed description

Emerging evidence suggests a notable prevalence of sleep-disordered breathing (SDB), including obstructive sleep apnea (OSA), as well as periodic limb movement disorder (PLMD) and insomnia in individuals with SSc. The multi-factorial aetiology of sleep disturbances in SSc may involve fibrotic changes in the lungs, gastroesophageal reflux, musculoskeletal discomfort, and psychological stress. Moreover, pulmonary fibrosis and restrictive lung disease in SSc have been linked to an increased risk of nocturnal hypoxia and sleep fragmentation, which may worsen fatigue and impair quality of life. Objective sleep assessment through PSG can provide essential insights into the type and severity of sleep disorders in SSc patients. Identifying these disorders early may guide more targeted management strategies, improve patients' daily functioning, and potentially alter disease outcomes. Hence, this study is warranted to fill the existing gap in knowledge and to explore the clinical implications of sleep disturbances in systemic sclerosis. Study Objectives is to assess the occurrence and types of sleep disorders in systemic sclerosis patients, to evaluate polysomnographic findings in systemic sclerosis disease.

Conditions

• Systemic Sclerosis
• Sleep-Disordered Breathing

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Polysomnography (PSG)	Polysomnography (PSG) is the gold standard, multi-parametric diagnostic test used to comprehensively assess sleep architecture and diagnose sleep disorders. This objective, overnight recording captures simultaneous physiological data channels, including electroencephalography (EEG) to stage sleep, electrooculography (EOG) to detect eye movements, electromyography (EMG) to measure muscle tone, electrocardiography (ECG) for heart rhythm, respiratory effort (via thoracic and abdominal belts), nasal airflow, and pulse oximetry for blood oxygen saturation. As the primary/secondary outcome measure, PSG will be administered to quantitatively evaluate the intervention's effect on key sleep parameters such as total sleep time (TST), sleep efficiency (SE), wake after sleep onset (WASO), latency to sleep onset, and the frequency of sleep-disordered breathing events (e.g., Apnea-Hypopnea Index, AHI) or periodic limb movements.

Timeline

• Start date: 2025-09-20
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: Egypt