Clinical trial NCT05790330: Mind and Skin - the Neurocutaneous Axis in Atopic Eczema
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2023-03-30
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: Patients aged 12-18 who have been diagnosed with eczema and require systemic therapy.

Group 2: Patients aged 12-18 who have been diagnosed with eczema and require topical therapy only.

Group 3: Patients aged 12-18 who do not have eczema.

Brief summary: '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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 12 to 18 with atopic eczema (groups 1 and 2), which has been diagnosed by a Consultant Dermatologist.
2. Patients with atopic eczema warranting systemic immuno-modulatory therapy or patients with atopic eczema on topical therapy or healthy controls.
3. 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.
4. Willingness to comply with all study requirements.
5. 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:

1. Insufficient understanding of the study by the patient and/or parent/guardian.
2. 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.
3. Any condition deemed by the Investigator to limit a patient's ability to undertake MRI components of the study, for example significant claustrophobia.
4. Diagnosed by a sleep medicine specialist with a formal sleep disorder, requiring systemic medication.
5. 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.
6. Previous and/or current substance misuse.
7. Patients who take medications that would, in the investigator's opinion, impact on quality of sleep studies.

Primary outcomes:
measure: Eczema Area and Severity Index (EASI) Score
timeFrame: 6 months
measure: Peak Pruritus Numerical Rating Score
timeFrame: 6 months
measure: Transepidermal water loss (TEWL)
timeFrame: 6 months
measure: Skin surface pH
timeFrame: 6 months
measure: Metabolome swab
timeFrame: 6 months
measure: Skin ELISA (enzyme-linked immunosorbent assay) and serum ELISA
timeFrame: 6 months
measure: RNA sequencing of blood serum
timeFrame: 6 months
measure: Pediatric Sleep Questionnaire
timeFrame: 6 months
measure: Morningness-Eveningness Questionnaire
timeFrame: 6 months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 months
measure: Dreem headband electroencephalogram monitoring
timeFrame: 6 months
measure: Polysomnography
timeFrame: 6 months
measure: Actigraphy Watch analysis
timeFrame: 6 months
measure: EMFIT mattress analysis
timeFrame: 6 months
measure: Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II) Score
timeFrame: 6 months
measure: Go/No-GO Task
timeFrame: 6 months
measure: Simon Task
timeFrame: 6 months
measure: Continuous Performance Task
timeFrame: 6 months
measure: Time Discrimination Task
timeFrame: 6 months
measure: Vigilance Task (Mackworth Clock)
timeFrame: 6 months
measure: Performance on Working Memory Task
timeFrame: 6 months
measure: Performance on Sustained Attention Task
timeFrame: 6 months
measure: Resting Brain State
timeFrame: 6 months
measure: Structural Changes in the Brain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Unit for Paediatric and Population-based Dermatology Research
Study officials:
References: