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NCT07483541
Identification of Modifiable Sleep-related Factors in Patients With Systemic Lupus Erythematosus.
trial testing Adults with systemic lupus erythematosus in Lupus Erythematosus in 250 participants. Not yet recruiting.
13 June 2026
Quick facts
| Lead sponsor | Investigación en Hemofilia y Fisioterapia |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 1 April 2026 |
| Primary completion | 13 June 2026 |
| Estimated completion | 11 August 2026 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Adults with systemic lupus erythematosus
Conditions studied
- Lupus Erythematosus — all drugs for Lupus Erythematosus →
Sponsor
Investigación en Hemofilia y Fisioterapia
Who can join
18 and older, any sex, with Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07483541
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07483541 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Investigación en Hemofilia y Fisioterapia
- Last refreshed: 19 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07483541.
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