NCT07483541Not yet recruiting
Identification of Modifiable Sleep-related Factors in Patients With Systemic Lupus Erythematosus.
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- May 2026
- Primary completion date
- Jun 2026
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Diseases
- Lupus (SLE)
- NCT number
- NCT07483541
What you commit to
- Study type: Observational
- Planned participants: 250
- From May 2026 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Psychiatric or cognitive impairment that may prevent or substantially limit the accurate completion of the questionnaires
Other
- Individuals whose usual occupation involves night or rotating shift work;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad de Oviedo Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.