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NCT Number: NCT05790330

Mind and Skin - the Neurocutaneous Axis in Atopic Eczema

'Mind and Skin': A prospective cohort study evaluating the impact of inflammation, itch and sleep disturbance on the brain, mental health and cognition, in patients with severe atopy.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unit for Paediatric and Population-based Dermatology Research

London, SE17EH, United Kingdom

Location status: Recruiting

Location contact

Carsten Flohr

CONTACT

[email protected]

020 7188 7188 ext. 57716

About this study

Atopic eczema is an intensely itchy skin disease which often starts in infancy or early childhood. It can have profound effects on patients' quality of life and cause long-lasting psychological impairment. Sleep may be very disturbed. More severe disease often requires oral/injectable immuno-modulatory treatments (i.e. medications which control symptoms by influencing the immune system).

There is an association between eczema, impaired cognitive functioning and mental health disorders, but the underlying mechanisms are not clearly defined.

This projects examines the links between inflammation-driven itching and disturbed sleep, and how this might be causally responsible for systemic and brain inflammation, disturbance of cognitive functioning and mental health problems. The investigators will also study potential changes occurring following an improvement in eczema when patients are treated with systemic immuno-modulators.

Key investigations will include:

i) Home-based sleep studies using a commercially available sleep devices (for example DREEM headband, Philips Actiwatch, oximetry) ii) Structural and functional magnetic resonance imaging (MRI) of the brain, iii) Blood tests to quantify systemic inflammation iv) Genetic analyses, particularly related to the immune system, circadian rhythm (the "internal 24-hour clock"), skin barrier function and the risk of developing eczema or associated diseases, v) Assessments of the skin's barrier function vi) Stool samples and skin swabs to study the gut and skin microbiome.

The investigators will utilise existing anonymised data for comparative purposes (e.g. from patients with Attention Deficit Hyperactivity Disorder (ADHD) and healthy controls who previously had brain imaging.)

The investigators will explore eczema patients' and families' perception of their disease, in particular itch and the resulting sleep loss, through focus groups, to better understand the sociological impact of eczema, and how these patients' interactions with the external world and society are affected by eczema. Importantly, this will include exploration of family dynamics, as patients with eczema often have profound sleep disturbance from early life, which can impact on their caregivers' sleep and quality of life.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 12 to 18 with atopic eczema (groups 1 and 2), which has been diagnosed by a Consultant Dermatologist.
  • Patients with atopic eczema warranting systemic immuno-modulatory therapy or patients with atopic eczema on topical therapy or healthy controls.
  • Written informed consent for study participation obtained from the patient or from the parent(s) / legal guardian, with assent as determined by the patient's age and level of understanding.
  • Willingness to comply with all study requirements.
  • Competent use of English language, according to patient's age (patients will be required to understand the written questionnaires and complying with instructions during MRI scanning).

Exclusion criteria

  • Insufficient understanding of the study by the patient and/or parent/guardian.
  • Any clear contra-indication to MRI scanning. In particular this would be due to the presence of any implanted devices or metal from previous surgery or accident. This would be fully assessed with a standardised safety questionnaire by a radiographer prior to MRI scanning.
  • Any condition deemed by the Investigator to limit a patient's ability to undertake MRI components of the study, for example significant claustrophobia.
  • Diagnosed by a sleep medicine specialist with a formal sleep disorder, requiring systemic medication.
  • Sleep disturbance from co-morbid illness (including physical and/or mental/psychological illness) other than atopic eczema, deemed by the Investigator to significantly impact on sleep components of the study.
  • Previous and/or current substance misuse.
  • Patients who take medications that would, in the investigator's opinion, impact on quality of sleep studies.

Treatment and study plan

methotrexate

Drug

As per usual standard of care

Dupilumab

Drug

As per usual standard of care

Primary outcomes

  1. Eczema Area and Severity Index (EASI) Score

    Time frame: 6 months

    Clinical assessment of atopic dermatitis disease activity. Range 0-72 (72 being the most severe outcome)

  2. Peak Pruritus Numerical Rating Score

    Time frame: 6 months

    Patient reported itch severity. Range 0-10 (10 being the worst outcome)

  3. Transepidermal water loss (TEWL)

    Time frame: 6 months

    Skin barrier function measurement using a device which measures the amount of water that passively evaporates through skin to the external environment due to water vapor pressure gradient on both sides of the skin barrier

  4. Skin surface pH

    Time frame: 6 months

    Skin barrier function measurement using a pH measuring device.

  5. Metabolome swab

    Time frame: 6 months

    Skin metabalome analysis using a skin swab

  6. Skin ELISA (enzyme-linked immunosorbent assay) and serum ELISA

    Time frame: 6 months

    Immunoassay detection and quantification

  7. RNA sequencing of blood serum

    Time frame: 6 months

    To detect transcript isoforms, gene fusions and single nucleotide variants.

  8. Pediatric Sleep Questionnaire

    Time frame: 6 months

    Sleep questionnaire. Score 18-126 (126 being the worst clinical outcome)

  9. Morningness-Eveningness Questionnaire

    Time frame: 6 months

    Sleep questionnaire. Score 16-86 assesses individual differences in morningness and eveningness - the degree to which respondents are active and alert at certain times of day.

  10. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 6 months

    Sleep questionnaire. Score 0-20 (0 being the worst clinical outcome)

  11. Pittsburgh Sleep Quality Index

    Time frame: 6 months

    Sleep questionnaires. Score 0-21 (21 being the worst clinical outcome)

  12. Dreem headband electroencephalogram monitoring

    Time frame: 6 months

    Sleep study - Measures brain activity to assess sleep cycles

  13. Polysomnography

    Time frame: 6 months

    Sleep study incorporating electroencephalogram, electro-oculogram, electromyogram, electrocardiogram, and pulse oximetry, as well as airflow and respiratory effort, to evaluate for underlying causes of sleep disturbances.

  14. Actigraphy Watch analysis

    Time frame: 6 months

    Watch is worn by participant which records movement during sleep to analyse sleep pattern

  15. EMFIT mattress analysis

    Time frame: 6 months

    Mattress sensor which records movement during sleep to analyse sleep pattern to analyse sleep pattern

  16. Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II) Score

    Time frame: 6 months

    Intelligence Quotient Test. Score 40-160 (40 being the worst clinical outcome)

  17. Go/No-GO Task

    Time frame: 6 months

    The Go/No-go task requires participants to respond by pressing a button when they see a "go" signal, and not respond when they see the "no-go" signal. The key behaviour measured with this experiment is the participants' ability to withhold a response on No-go trials. This is scored as a fraction of correct responses.

  18. Simon Task

    Time frame: 6 months

    In this task participants are asked to respond to visual stimuli by making a rightward response to one stimulus (e.g. a circle) and a leftward response to another (e.g. a square). This is scored as a fraction of correct responses.

  19. Continuous Performance Task

    Time frame: 6 months

    In this task participants are asked to only respond to a specific sequence of visual stimuli. This is scored as a fraction of correct responses.

  20. Time Discrimination Task

    Time frame: 6 months

    In this task participants are ask to decide which stimuli stayed on screen for the longest duration. This is scored as a fraction of correct responses.

  21. Vigilance Task (Mackworth Clock)

    Time frame: 6 months

    In this task participants are asked to watched a clock hand that moves every second around the clock. From time to time the hand skips a second and participants need to respond to this. This is scored as a fraction of correct responses.

  22. Performance on Working Memory Task

    Time frame: 6 months

    Completed in functional MRI

  23. Performance on Sustained Attention Task

    Time frame: 6 months

    Completed in functional MRI

  24. Resting Brain State

    Time frame: 6 months

    Measured in functional MRI

  25. Structural Changes in the Brain

    Time frame: 6 months

    Structure of the brain is measured in MRI

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

Registry information

Official study title

'Mind and Skin': A Prospective Cohort Study Evaluating the Impact of Inflammation, Itch and Sleep Disturbance on the Brain, Mental Health and Cognition, in Patients With Severe Atopy

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Mar 30, 2023
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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