Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790330
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2022-09-02
Brief Title:
Mind and Skin - the Neurocutaneous Axis in Atopic Eczema
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 oralinjectable immuno-modulatory treatments ie 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 skins 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 eg 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
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 skins 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None