Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-03

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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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

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Atopic Dermatitis Sleep Disturbance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants with atopic dermatitis

No interventions assigned to this group

Infants without atopic dermatitis

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes