Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

Not yet recruiting

• Conditions: Systemic Sclerosis; Sleep-Disordered Breathing

• Registration Number: NCT07175246
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-21
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-09-20
• Primary Completion: 2026-08-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Assiut University hospital; 🇪🇬 Asyut, Asyut Governorate, Egypt