An observational study in Lupus Erythematosus, sponsored by Investigación en Hemofilia y Fisioterapia. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Investigación en Hemofilia y Fisioterapia · Observational
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.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 250 is above the median of 151 across 280 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Investigación en Hemofilia y Fisioterapia is the lead sponsor of 57 studies on the registry; 7 are open to participants now.
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Adults with systemic lupus erythematosus
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with systemic lupus erythematosus
Other: Adults with systemic lupus erythematosus
Patients with systemic lupus erythematosus included in the study will complete validated questionnaires to address the study objectives.
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.
Time frame: Screening visit
Measurement of physical activity
The independent variable will be physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), an instrument that records the frequency, duration, and intensity of physical activity performed during the previous week and allows results to be expressed in MET·minutes/week. According to the criteria established by the World Health Organization, participants will be classified into low, moderate, or high levels of physical activity.
Time frame: Screening visit
Measurement of caffeine consumption
The independent variable will be caffeine consumption, assessed by recording the average number of daily servings of caffeinated beverages, including coffee, tea, energy drinks, and caffeinated soft drinks. Participants will report the average number of servings consumed per day according to beverage type, as well as the usual time of the last caffeine intake, given that the effect of caffeine on sleep may depend on the timing of consumption. Caffeine intake will be categorized into low, moderate, or high consumption according to standard epidemiological criteria (e.g., \<1 unit/day, 1-2 units/day, ≥3 units/day). For measurement purposes, participants will be asked questions such as: "How many caffeine units do you consume per day? (1 cup of coffee = 1 unit; 1 energy drink = 2 units)" and "At what time do you usually consume your last caffeinated beverage?"
Time frame: Screening visit
Measurement of alcohol consumption
The independent variable will be alcohol consumption, assessed by recording both the frequency and quantity of alcohol intake. Frequency will be categorized as never, monthly, weekly, or daily. Quantity will be measured in standard drink units (1 drink = 10 g of alcohol), and participants will report the number of units consumed during a typical week. Additionally, participants will be asked about evening or nighttime alcohol consumption, specifically whether alcohol is consumed within the 3-4 hours prior to bedtime, as this timing may influence sleep quality. Example questions include: "How many units of alcohol do you consume in a typical week?" and "Do you usually consume alcohol in the evening or at night?"
Time frame: Screening visit
Measurement of tobacco consumption
The independent variable will be tobacco consumption, assessed by recording the number of cigarettes smoked per day. Alternatively, smoking status will be categorized as non-smoker, former smoker, occasional smoker, or daily smoker. Participants will also be asked whether they smoke during the hour before going to bed, given the potential stimulating effects of nicotine on sleep. Example questions include: "How many cigarettes do you smoke per day?" and "Do you smoke during the hour before going to sleep?"
Time frame: Screening visit
Measurement of medications affecting sleep
The independent variable will be the use of medications that may affect sleep, including hypnotics, anxiolytics, antidepressants, and stimulants. Participants will be asked whether they take any of these medications, which specific drugs they use, and the timing of administration. This variable will be primarily categorized as dichotomous (yes/no), and additional information may be collected regarding the pharmacological class and whether the medication is taken under medical prescription or through self-medication. Example questions include: "Do you take any medication to help you sleep, for anxiety, depression, or to stay awake? Please indicate which ones." and "Do you usually take these medications at night?"
Time frame: Screening visit
Measurement of sleep schedule (sleep-wake rhythm)
The independent variable will be sleep schedule, assessed by recording participants' usual bedtime and wake-up time. Information will also be collected regarding potential variability between weekdays and weekends to evaluate the regularity of the sleep-wake rhythm. Example questions include: "What time do you usually go to bed on weekdays?" and "What time do you usually wake up on weekends?"
Time frame: Screening visit
Measurement of sleep regularity (variability in sleep schedule)
The independent variable will be sleep regularity, assessed by evaluating the variability in habitual sleep schedules across different days of the week. Participants will be asked whether their usual bedtime varies by more than one hour between days, a criterion commonly used in circadian rhythm research. This variable will be recorded as a dichotomous measure (yes/no). Example question: "Does the time at which you usually go to bed vary by more than one hour across different days of the week?"
Time frame: Screening visit
Measurement of napping habits
The independent variable will be napping habits, assessed by recording the weekly frequency and typical duration of daytime naps. Nap duration will be categorized into standard intervals commonly used in sleep research: \<30 minutes, 30-60 minutes, and \>60 minutes. Participants will be asked questions such as: "Do you take naps? If yes, how often per week?" and "How long do your naps usually last?"
Time frame: Screening visit
Measurement of screen use before bedtime
The independent variable will be screen use during the hour before bedtime, assessed by recording the frequency, type of device, and duration of exposure. Frequency will be categorized as never, less than 2 days per week, several days per week, or daily. Participants will also report the type of device used (e.g., smartphone, computer, television, or tablet) and the typical duration of screen exposure (\<30 minutes, 30-60 minutes, or \>60 minutes). Example question: "During the hour before going to sleep, do you use screens? Please indicate the frequency and duration of use."
Time frame: Screening visit
Measurement of bedroom environment
The independent variable will be bedroom environment, assessed through self-reported evaluation of environmental conditions during sleep, including light, noise, temperature, and comfort. These factors will be measured using a Likert scale ranging from 1 to 5. Participants will also be asked about the presence of potentially disruptive stimuli in the bedroom, such as the presence of a mobile phone, television, or pets in the bed. Example questions include: "Rate from 1 to 5 how much light is present in your bedroom while sleeping." and "Are there frequent noises during the night?"
Time frame: Screening visit
Measurement of pre-sleep stress or cognitive arousal
The independent variable will be pre-sleep stress or cognitive arousal, assessed by asking participants about the presence of stress, worry, or intrusive thoughts during the period before bedtime. This variable will be measured using a Likert scale ranging from 1 to 5, where higher scores indicate greater levels of stress or cognitive activation prior to sleep. Example question: "During the hour before going to sleep, how often do you experience stress, worry, or mental rumination?"
Time frame: Screening visit
Measurement of pre-sleep activities
The independent variable will be pre-sleep activities, assessed by recording the frequency of behaviors performed before bedtime that may negatively or positively influence sleep. Participants will report the frequency (never, rarely, sometimes, often, always) of specific activities, including heavy evening meals, vigorous nighttime physical exercise, hot showers or relaxation rituals, and relaxing activities such as reading, meditation, or listening to soft music.
Time frame: Screening visit
Measurement of risk of obstructive sleep apnea
The secondary variable will be the risk of obstructive sleep apnea, assessed using the STOP-Bang questionnaire, a brief self-administered screening tool composed of eight dichotomous items (yes/no). The questionnaire evaluates snoring, daytime sleepiness, observed apneas, hypertension, elevated body mass index, age, neck circumference, and sex. The STOP-Bang has demonstrated high sensitivity for the detection of obstructive sleep apnea across different clinical and population settings and has previously been used in studies involving individuals with systemic lupus erythematosus to estimate the risk of sleep-disordered breathing.
Time frame: Screening visit
Measurement of relevant comorbidities
The secondary variable will be the presence of relevant comorbidities, including fibromyalgia, depression, and sleep-related breathing disorders. These conditions will be recorded as dichotomous clinical variables (presence/absence) based on information obtained from the patient's medical history and self-report.
Time frame: Screening visit
Measurement of daytime sleepiness
The secondary variable will be daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS), a self-administered questionnaire designed to estimate the general level of daytime sleepiness. The instrument consists of eight items that evaluate the likelihood of falling asleep in different common daily situations, generating a total score ranging from 0 to 24, with higher scores indicating greater daytime sleepiness. The ESS has demonstrated the ability to discriminate between healthy individuals and patients with different sleep disorders and has shown correlations with objective measures of sleepiness and sleep-disordered breathing.
Time frame: Screening visit
Measurement of perceived stress
The secondary variable will be perceived stress assessed using the 10-item Perceived Stress Scale (PSS-10), a self-administered questionnaire designed to measure the degree to which situations in one's life are appraised as stressful during the previous month. Each item is scored on a Likert-type scale from 0 to 4, yielding a total score ranging from 0 to 40, with higher scores indicating greater levels of perceived stress. The PSS has demonstrated adequate psychometric properties, including good reliability and validity, and has been shown to correlate with depressive and physical symptoms, life events, and health-related behaviors, supporting its use as a valid measure of perceived stress as an independent construct. Moreover, it has been recently used in studies involving individuals with systemic lupus erythematosus, supporting its applicability in this population.
Time frame: Screening visit
Plan to share: No
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Start is estimated for May 2026; primary completion for Jun 2026, 1 month later.
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Lupus Erythematosus, Systemic →
Investigación en Hemofilia y Fisioterapia