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NCT Number: NCT07175246

Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 71515, Egypt

Location contact

Ashraf Zin El-Abdeen Mohamed, Prof

SUB_INVESTIGATOR

Eman Ahmed Abd Elhamed, Resident

CONTACT

[email protected]

+21010363485

Lamiaa Hassan Shaaban, Prof

SUB_INVESTIGATOR

Waleed Gamal Elddin, Ass. Prof.

CONTACT

[email protected]

+21006519722

Waleed Gamal Elddin, Ass. Prof.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography (PSG)

Diagnostic Test

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.

Primary outcomes

  1. sleep disorders in systemic sclerosis patients

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Ahmed Abd Elhamed, Resident

CONTACT

[email protected]

+21010363485

Waleed Gamal Elddin, ass. prof

CONTACT

[email protected]

+21006519722

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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