Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation

Study Overview
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Brief Summary
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The SPINDLE study will examine sleep in infants with atopic dermatitis by serial assessment over the first year of life, in comparison to infants without atopic dermatitis. Sleep will be assessed using electroencephalography, actigraphy, and sleep questionnaires.

Detailed Description
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Infants will be recruited at 6 to 8 months and followed up until 18 months of age. Sleep electroencephalography will be performed at 6 to 8 months. Sleep actigraphy will be performed at 6 to 8 months and 12 months. Infant sleep questionnaires will be completed on a monthly basis, and parental sleep questionnaires will be completed at 6 to 8 months, 9 to 10 months, and 12 months. A neurodevelopmental assessment will be performed at 18 months.

Official Title
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Assessing SleeP IN Infants With Early-onset Atopic Dermatitis by Longitudinal Evaluation

Conditions
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Atopic Dermatitis, Sleep Disturbance

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Moderate to severe atopic dermatitis Exclusion Criteria: Premature birth (under 37 weeks gestation) Severe medical condition (such as epidermolysis bullosa or ichthyosis) at time of enrolment that would complicate assessment for AD or preclude the use of investigational tools, or other major health problems (especially genetic or metabolic) that would have implications for neurodevelopment Any medical condition requiring the using of sedating medications (eg antihistamines)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with atopic dermatitis<br>Infants with atopic dermatitis | |
| Infants without atopic dermatitis<br>Infants without atopic dermatitis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Altered macrostructure of sleep from 6 to 12 months measured with parental sleep diaries | Measured as decreased sleep efficiency and increased night time awakenings | 6 months to 12 months | 
| Altered macrostructure of sleep at 6 and 12 months measured by nocturnal actigraphy | Measured as sensor-detected movement | 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Altered microstructure of sleep at six-eight months using electroencephalography to measure sleep spindle power in rapid eye movement and non-rapid eye movement stages | Measured as sleep spindle power and power in rapid eye movement (REM) and non-rapid eye movement (NREM) sleep stages | 6-8 months | 
| Parental sleep quality and quality of life measured using the Pittsburgh Sleep Quality Index (PSQI) | Measured using standardized questionnaire (PSQI) | 6 months to 12 months |