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Not yet recruiting NCT07175246

Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

— Observational Systemic Sclerosis Sleep-Disordered Breathing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polysomnography (PSG).
Who it may be relevant to
Registry conditions: Systemic Sclerosis, Sleep-Disordered Breathing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • sleep disorders in systemic sclerosis patients [Time frame: 6 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Egypt · 1 center
  • Assiut University hospital — Asyut

Publications

  • Cholerzynska H, Zasada W, Tselios K, Grygiel-Gorniak B. Sleep Disorders in Connective Tissue Diseases-Coexisting Diseases or Disease Components? J Clin Med. 2024 Jun 22;13(13):3656. doi: 10.3390/jcm13133656. PMID 38999222
  • Wongthawa N, So-Gnern A, Mahakkanukrauh A, Suwannaroj S, Foocharoen C. Sleep quality and clinical association with sleep disturbance in systemic sclerosis. BMC Rheumatol. 2023 Jul 21;7(1):21. doi: 10.1186/s41927-023-00346-7. PMID 37480089

Identifiers

NCT: NCT07175246 · Sleep-systemic-sclerosis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗