Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation (SPINDLE)

University College Cork (UCC)

Status

Unknown

Conditions

Atopic Dermatitis

Sleep Disturbance

Study type

Observational

Funder types

Other

Identifiers

NCT05031754

223047/Z/21/Z

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

6 to 18 months old

Volunteers

Accepts Healthy Volunteers

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)