Identification of Modifiable Sleep-related Factors in Patients With Systemic Lupus Erythematosus.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Measurement of sleep quality
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Observational group
Adults with systemic lupus erythematosus
干预措施: Adults with systemic lupus erythematosus (Other)
结局指标
主要结局
Measurement of sleep quality
时间窗: Screening visit
The primary variable will be sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-administered questionnaire composed of 19 items grouped into seven components. The global score ranges from 0 to 21 points, with scores \>5 indicating poor sleep quality. This instrument has demonstrated adequate psychometric properties in patients with systemic lupus erythematosus.
次要结局
- Measurement of sleep hygiene(Screening visit)
- Measurement of physical activity(Screening visit)
- Measurement of caffeine consumption(Screening visit)
- Measurement of alcohol consumption(Screening visit)
- Measurement of tobacco consumption(Screening visit)
- Measurement of medications affecting sleep(Screening visit)
- Measurement of sleep schedule (sleep-wake rhythm)(Screening visit)
- Measurement of sleep regularity (variability in sleep schedule)(Screening visit)
- Measurement of napping habits(Screening visit)
- Measurement of screen use before bedtime(Screening visit)
- Measurement of bedroom environment(Screening visit)
- Measurement of pre-sleep stress or cognitive arousal(Screening visit)
- Measurement of pre-sleep activities(Screening visit)
研究者
Rubén Cuesta-Barriuso
Principal Investigator
Investigación en Hemofilia y Fisioterapia