Incidence, management, and impact of sleep disturbance in children and adolescents with atopic dermatitis: a retrospective matched cohort study in the UK

Study type
Protocol
Date of Approval
Study reference ID
24_003768
Lay Summary

Eczema, also known as atopic dermatitis, is a common skin condition affecting 1 in 10 children. One of the biggest problems with eczema is the itching, especially at night. This can make it hard for children to fall and stay asleep, leading to nearly an hour less sleep each night compared to children without eczema. Not getting enough sleep can affect a child's mood, behaviour, and learning. It can also make it tough for parents and siblings to get a good night's rest.

Treating both itching and sleep problems can be tricky. Some older allergy medications (sedating antihistamines), can help but these medications should only be used for a short period. Melatonin is a natural hormone in the body that helps regulate sleep. Sometimes doctors prescribe melatonin to help with sleep problems. Previous studies have suggested that melatonin might be helpful for children with eczema. We're interested in learning more about the which of these treatments’ doctors are prescribing for children with eczema and sleep problems.

We also want to explore why some children with eczema are more at risk of having sleep problems than other children. We're interested in seeing if children who struggle with both eczema and sleep issues are more likely to experience anxiety, depression, or other mental health challenges.

This research will help doctors understand which children with eczema are most at risk of sleep problems. Getting a better understanding can help ensure that children with both eczema and sleep problems get the support they need.

Technical Summary

Atopic dermatitis (AD) is the most common skin condition in childhood, affecting 9.6% of children [1]. AD has been associated with sleep disturbance [2-6], which can impact on behaviour [2], school and work [3, 6, 7]. Large-scale population-based research is need to investigate the total burden of sleep in children and adolescents with AD, as well as identifying which groups are at greatest risk of sleep disturbance and the subsequent impact it can have on mental health.

We will use a matched cohort study to assess the risk of sleep disturbance in children with active AD. Primary outcomes will be the relative risk of sleep disturbance in those with active AD compared to unaffected controls, including across subgroups, using Kaplan-Meier survival functions and Cox proportional hazard models. As a secondary objective we will also compare mental health outcomes in children with AD with and without sleep disturbance.

We will investigate the relative use of medications, including sedating antihistamines, non-sedating antihistamines and melatonin, in children with active AD with and without sleep disturbance, using unadjusted prescribing rates (prescriptions per 100 person years) and Poisson regression models. We will describe changes in prescribing trends of these medications over the last 20 years.

The study cohort will include children and adolescents aged 2-17 years registered in CPRD Aurum with active AD between March 1, 2003 and March 1 2023. Active AD will be defined using a combination of specific diagnosis codes and two or more AD related treatments prescribed on different dates. Cases will be matched up to 1:4 with unaffected controls at the same GP practice. A combination of time-dependent propensity score and exact matching will be applied, based on age, sex, ethnicity, socioeconomic deprivation and duration of practice registration.

Health Outcomes to be Measured

Sleep disturbance will be identified in the primary care record. A final code list will be developed based on the provisional list in Appendix 1. Prior to finalizing this outcome, the impact of extending the outcome definition to include treatment specific to sleep disturbance (i.e. melatonin prescription) but without a diagnosis code for sleep disturbance will be explored.

Medication includes non-sedating antihistamines, sedating antihistamines and melatonin.

Mental health outcomes: Common mental health conditions in children and adolescents [8]; comprising anxiety, depression [9], ADHD, and behavioural disorders.

Collaborators

Melissa Watkins - Chief Investigator - Pfizer Inc - US Headquarters
Emma Jones - Corresponding Applicant - Momentum Data Ltd
Andrew McGovern - Collaborator - Momentum Data Ltd
Anita Lynam - Collaborator - Momentum Data Ltd
Carsten Flohr - Collaborator - King's College London (KCL)
Maciej Czachorowski - Collaborator - Pfizer Ltd - UK
Mary Araghi ( Gerino ) - Collaborator - Pfizer Ltd - UK
Muhammad (Ashkan) Dashtban - Collaborator - Momentum Data Ltd
Serhan Bahit - Collaborator - Momentum Data Ltd

Linkages

ONS Death Registration Data;Patient Level Index of Multiple Deprivation