Identification of Modifiable Sleep-related Factors in Patients With Systemic Lupus Erythematosus.
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: Adults with systemic lupus erythematosus.
- Кому может быть актуально
- Состояния в реестре: Lupus Erythematosus. 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
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Background: Sleep quality is a key determinant of physical and mental health, with important implications for immune regulation, psychological well-being, and overall quality of life. In systemic lupus erythematosus (SLE), sleep disturbances are highly prevalent and have been associated with poorer clinical and psychosocial outcomes. However, the specific contribution of potentially modifiable behavioral and environmental factors to sleep quality in this population has been insufficiently investigated. Objectives: To analyze the association between modifiable lifestyle, behavioral, and environmental factors and sleep quality in adults with systemic lupus erythematosus. Methods: A multicenter cross-sectional observational study will be conducted. Approximately 250 adults with systemic lupus erythematosus from different regions of Spain will be included. The primary outcome will be sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI). Independent variables will include physical activity (International Physical Activity Questionnaire-Short Form), substance use, sleep timing and regularity, napping habits, screen exposure, and bedroom environmental conditions. Secondary variables will include risk of obstructive sleep apnea (STOP-Bang questionnaire), daytime sleepiness (Epworth Sleepiness Scale), perceived stress (Perceived Stress Scale-10), as well as clinical, sociodemographic, and anthropometric variables. Expected results: To identify behavioral and environmental factors independently associated with poor sleep quality in individuals with systemic lupus erythematosus and to estimate the prevalence of poor sleep quality in the study sample.
Вмешательства
- Другое Adults with systemic lupus erythematosus
Patients with systemic lupus erythematosus included in the study will complete validated questionnaires to address the study objectives.
Первичные конечные точки
- Measurement of sleep quality [Срок оценки: Screening visit]
Вторичные конечные точки (12)
- Measurement of physical activity [Срок оценки: Screening visit]
- Measurement of caffeine consumption [Срок оценки: Screening visit]
- Measurement of alcohol consumption [Срок оценки: Screening visit]
- Measurement of tobacco consumption [Срок оценки: Screening visit]
- Measurement of medications affecting sleep [Срок оценки: Screening visit]
- Measurement of sleep schedule (sleep-wake rhythm) [Срок оценки: Screening visit]
- Measurement of sleep regularity (variability in sleep schedule) [Срок оценки: Screening visit]
- Measurement of napping habits [Срок оценки: Screening visit]
- Measurement of screen use before bedtime [Срок оценки: Screening visit]
- Measurement of bedroom environment [Срок оценки: Screening visit]
- Measurement of pre-sleep stress or cognitive arousal [Срок оценки: Screening visit]
- Measurement of pre-sleep activities [Срок оценки: Screening visit]
Критерии участия
Критерии включения
- Adults aged ≥18 years;
- A medical diagnosis of systemic lupus erythematosus (according to current clinical classification criteria);
- Both sexes;
- Clinically stable condition during the previous 3 months; and
- Provision of written informed consent.
Критерии исключения
- Individuals whose usual occupation involves night or rotating shift work;
- A previous diagnosis of a primary sleep disorder receiving specific treatment (e.g., severe obstructive sleep apnea treated with CPAP, narcolepsy, or other central sleep disorders); and
- Psychiatric or cognitive impairment that may prevent or substantially limit the accurate completion of the questionnaires
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Испания · 1 центр
- Universidad de Oviedo — Oviedo
Идентификаторы
NCT: NCT07483541 · LupSleep