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Lupus ErythematosusNCT07483541

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

An observational study of Lupus Erythematosus, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lupus Erythematosus
What is being tested?
Adults with systemic lupus erythematosus
How many people
250 participants
Where
1 siteSpain
Study dates
5 May 2026to 25 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults with systemic lupus erythematosus

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rubén Cuesta-Barrius, PhD contact

0034 985103386

cuestaruben@uniovi.es

Spain1 site
  • Universidad de Oviedo

    Oviedo, Asturias, Principado de, 33006

    Ruben Cuesta-Barriuso, PhD, 0034 985 103 386, cuestaruben@uniovi.es

Other trials in Spain

About this study

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.

Read more

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.

Being tested
Adults with systemic lupus erythematosus
Keywords
Systemic lupus erythematosus, Sleep quality, Sleep hygiene, Lifestyle, Physical activity
Medical subject headings
Lupus Erythematosus, Systemic, Sleep Initiation and Maintenance Disorders, Sleep Hygiene, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adults with systemic lupus erythematosusOther

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

Study groups in NCT07483541
Study groupRoleWhat they receive
Observational groupAdults with systemic lupus erythematosus
Receives: Other: Adults with systemic lupus erythematosus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Screening visit

Secondary outcomes (12)
  1. 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.

    Measured: Screening visit

  2. 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?"

    Measured: Screening visit

  3. 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?"

    Measured: Screening visit

  4. 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?"

    Measured: Screening visit

  5. 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?"

    Measured: Screening visit

  6. 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?"

    Measured: Screening visit

  7. 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?"

    Measured: Screening visit

  8. 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?"

    Measured: Screening visit

  9. 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."

    Measured: Screening visit

  10. 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?"

    Measured: Screening visit

  11. 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?"

    Measured: Screening visit

  12. 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.

    Measured: Screening visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start5 May 2026 (estimated)
  3. Primary completion13 Jun 2026 (estimated)
  4. Study completion25 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07483541
Sponsor's protocol ID
LupSleep
Status last verified
Apr 2026
First submitted
16 Mar 2026
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lupus Erythematosus, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rubén Cuesta-Barrius, PhD (0034 985103386, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of sleep quality (time frame: Screening visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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