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Набор скоро начнётся NCT07175246

Exploring the Patterns of Sleep Disordered Breathing in Systemic Sclerosis Patients

— Наблюдательное Systemic Sclerosis Sleep-Disordered Breathing

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Polysomnography (PSG).
Кому может быть актуально
Состояния в реестре: Systemic Sclerosis, Sleep-Disordered Breathing. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Обзор

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).

Подробное описание

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.

Вмешательства

  • Диагностический тест 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

Первичные конечные точки

  • sleep disorders in systemic sclerosis patients [Срок оценки: 6 hours]

Критерии участия

Критерии включения

Age ≥ 18 years, with Confirmed diagnosed of SSc (2013 ACR/EULAR criteria).

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Египет · 1 центр
  • Assiut University hospital — Asyut

Публикации

  • 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

Идентификаторы

NCT: NCT07175246 · Sleep-systemic-sclerosis

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗