NCT05031754

Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University College Cork · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Atopic Dermatitis
• Sleep Disturbance

Timeline

• Start date: 2020-12-03
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2021-09-02
• Last updated: 2022-05-27

Locations

1 site across 1 country: Ireland