Identification of Modifiable Sleep-related Factors in Patients With Systemic Lupus Erythematosus.

Condition(s) studied

Investigational drug(s) / intervention(s)

Adults with systemic lupus erythematosus: Patients with systemic lupus erythematosus included in the study will complete validated questionnaires to address the study objectives.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Measurement of sleep quality — 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.

Trial sites (1)

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