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

NCT07483541 | Not Yet Recruiting

• 1 other identifier: LupSleep
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lupus Erythematosus

Keywords

Systemic lupus erythematosus; Sleep quality; Sleep hygiene; Lifestyle; Physical activity

Outcome Measures

Primary Outcomes (1)

• Measurement of sleep quality

  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.

  Screening visit

Secondary Outcomes (12)

• Measurement of physical activity

  Screening visit

• Measurement of caffeine consumption

  Screening visit

• Measurement of alcohol consumption

  Screening visit

• Measurement of tobacco consumption

  Screening visit

• Measurement of medications affecting sleep

  Screening visit

Other Outcomes (4)

• Measurement of risk of obstructive sleep apnea

  Screening visit

• Measurement of relevant comorbidities

  Screening visit

• Measurement of daytime sleepiness

  Screening visit

Study Arms (1)

Observational group

Adults with systemic lupus erythematosus

Other: Adults with systemic lupus erythematosus

Interventions

Adults with systemic lupus erythematosus OTHER

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

Observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with systemic lupus erythematosus

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

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Universidad de Oviedo

Oviedo, Asturias, Principado de, 33006, Spain

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Sleep Initiation and Maintenance Disorders; Sleep Hygiene; Motor Activity

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior

Central Study Contacts

Rubén Cuesta-Barrius, PhD

CONTACT

0034 985103386; cuestaruben@uniovi.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: May 5, 2026
• Primary Completion: June 13, 2026
• Study Completion: July 25, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)