Clinical trial NCT05031754: Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation
Official title: Assessing SleeP IN Infants With Early-onset Atopic Dermatitis by Longitudinal Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Sleep Disturbance
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Health Service Executive, Ireland
name: Health Research Board, Ireland
First posted: 2021-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants under six months of age diagnosed with moderate to severe AD are eligible for the study. Healthy control infants, matched in age, will be recruited for the study.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Altered macrostructure of sleep from 6 to 12 months measured with parental sleep diaries
timeFrame: 6 months to 12 months
measure: Altered macrostructure of sleep at 6 and 12 months measured by nocturnal actigraphy
timeFrame: 6 months, 12 months
Secondary outcomes:
measure: 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
timeFrame: 6-8 months
measure: Parental sleep quality and quality of life measured using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months to 12 months
Other outcomes:
measure: Severity of atopic dermatitis in cases as assessed using SCORAD (SCORing Atopic Dermatitis)
timeFrame: 6 months to 12 months
measure: Severity of atopic dermatitis in cases as assessed using the Eczema Area and Severity Index (EASI)
timeFrame: 6 months to 12 months
measure: Severity of atopic dermatitis in cases as assessed using Investigator's Global Assessment scale (IGA)
timeFrame: 6 months to 12 months
measure: Neurodevelopmental assessment
timeFrame: At 18 months of age (one-off assessment)
Locations:
city: Cork
country: Ireland
facility: INFANT
Study officials:
affiliation: INFANT, University College Cork
name: Geraldine Boylan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connor C, Irvine AD, Murray D, Murphy M, O'B Hourihane J, Boylan G. Study protocol: assessing SleeP IN infants with early-onset atopic Dermatitis by Longitudinal Evaluation (The SPINDLE study). BMC Pediatr. 2022 Jun 18;22(1):352. doi: 10.1186/s12887-022-03382-3.