Systemic Sclerosis, Sleep-Disordered Breathing
Conditions
Keywords
systemic sclerosis, Sleep Apnea, Insomnia
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.
Interventions
DIAGNOSTIC_TESTPolysomnography (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.
Sponsors
Assiut University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactEman Ahmed Abd Elhamed, Resident
Backup ContactWaleed Gamal Elddin, ass. prof
Outcome results
None listed