Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation

Atopic Dermatitis Clinical Trial

— SPINDLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031754
• Other study ID #: 223047/Z/21/Z
• Status: Recruiting
• Start date: December 3, 2020
• Est. completion date: July 2023

Study information

• Verified date: May 2022
• Source: University College Cork
• Contact: Cathal O'Connor, MD
• Phone: +353877919176
• Email: cathal.oconnor[@]ucc.ie
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Dyssomnias
• Eczema
• Parasomnias
• Sleep Disturbance

Locations

Country	Name	City	State
Ireland	INFANT	Cork

Sponsors (4)

Lead Sponsor	Collaborator
University College Cork	Health Research Board, Ireland, Health Service Executive, Ireland, Wellcome Trust

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity of atopic dermatitis in cases as assessed using SCORAD (SCORing Atopic Dermatitis)	Measured using standardized clinical assessment score (SCORAD)	6 months to 12 months
Other	Severity of atopic dermatitis in cases as assessed using the Eczema Area and Severity Index (EASI)	Measured using standardized clinical assessment score (EASI)	6 months to 12 months
Other	Severity of atopic dermatitis in cases as assessed using Investigator's Global Assessment scale (IGA)	Measured using standardized clinical assessment scores (IGA)	6 months to 12 months
Other	Neurodevelopmental assessment	Measured using novel touchscreen app ('Cognitot')	At 18 months of age (one-off assessment)
Primary	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
Primary	Altered macrostructure of sleep at 6 and 12 months measured by nocturnal actigraphy	Measured as sensor-detected movement	6 months, 12 months
Secondary	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
Secondary	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