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NCT07175246

Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

Sponsor: Assiut University

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-09-20

Completion Date

2026-10-01

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

Assiut University hospital

Asyut, Asyut Governorate, Egypt