Identification of Modifiable Sleep-related Factors in Patients With Systemic Lupus Erythematosus.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adults with systemic lupus erythematosus.
- Who it may be relevant to
- Registry conditions: Lupus Erythematosus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Adults with systemic lupus erythematosus
Patients with systemic lupus erythematosus included in the study will complete validated questionnaires to address the study objectives.
Primary outcome measures
- Measurement of sleep quality [Time frame: Screening visit]
Secondary outcome measures (12)
- Measurement of physical activity [Time frame: Screening visit]
- Measurement of caffeine consumption [Time frame: Screening visit]
- Measurement of alcohol consumption [Time frame: Screening visit]
- Measurement of tobacco consumption [Time frame: Screening visit]
- Measurement of medications affecting sleep [Time frame: Screening visit]
- Measurement of sleep schedule (sleep-wake rhythm) [Time frame: Screening visit]
- Measurement of sleep regularity (variability in sleep schedule) [Time frame: Screening visit]
- Measurement of napping habits [Time frame: Screening visit]
- Measurement of screen use before bedtime [Time frame: Screening visit]
- Measurement of bedroom environment [Time frame: Screening visit]
- Measurement of pre-sleep stress or cognitive arousal [Time frame: Screening visit]
- Measurement of pre-sleep activities [Time frame: Screening visit]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Universidad de Oviedo — Oviedo
Identifiers
NCT: NCT07483541 · LupSleep