Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

NCT07175246 · tracked via the Priya Life Science Egypt tracker

Sponsor

Assiut University

Phase

Observational

Started

2025-09-20

Last updated

2025-09-16

Condition(s) studied

Systemic SclerosisSleep-Disordered Breathing

Investigational drug(s) / intervention(s)

Polysomnography (PSG)

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Age ≥ 18 years, with Confirmed diagnosed of SSc (2013 ACR/EULAR criteria). Exclusion Criteria: * Pre-existing primary sleep disorders diagnosed before SSc diagnosis * Use of sedatives or hypnotics within the last month that significantly alter sleep architecture * Severe psychiatric or neurological conditions * Refusal to participate in the study

Primary outcome measure(s)

sleep disorders in systemic sclerosis patients — 6 hours
Apnea-Hypopnea Index (AHI) Description: Average number of apneas and hypopneas per hour of sleep, assessed by overnight polysomnography. Unit of Measure: Events per hour Time Frame: 6 hours

Trial sites (1)

Facility	City	Region	Status
Assiut University hospital	Asyut	Asyut Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07175246 on ClinicalTrials.gov ↗ ← All trials in Egypt