Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation

• Conditions: Atopic Dermatitis; Sleep Disturbance

• Registration Number: NCT05031754
• Lead Sponsor: University College Cork

Brief 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.

Study Timeline

• Study Start: 2020-12-03
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-09-01
• Study First Posted: 2021-09-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	6-8 months	Measured as sleep spindle power and power in rapid eye movement (REM) and non-rapid eye movement (NREM) sleep stages
Parental sleep quality and quality of life measured using the Pittsburgh Sleep Quality Index (PSQI)	6 months to 12 months	Measured using standardized questionnaire (PSQI)

Trial Locations

Locations (1)

INFANT; 🇮🇪 Cork, Ireland