NCT07483541

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Investigación en Hemofilia y Fisioterapia · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 sleep hygiene (Sleep Hygiene Index), 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.

Conditions

• Lupus Erythematosus

Interventions

Type	Name	Description
OTHER	Adults with systemic lupus erythematosus	Patients with systemic lupus erythematosus included in the study will complete validated questionnaires to address the study objectives.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-06-13
• Completion: 2026-08-11
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Spain