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

Starting soon

Conditions studied: Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT07483541

Run by

Investigación en Hemofilia y Fisioterapia

People needed

250

Starts

2026-05-05

Expected to finish

2026-07-25

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Universidad de Oviedo — Oviedo, Asturias, Principado de, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.