Atopic Dermatitis, Sleep Disturbance
Conditions
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.
Interventions
None listed
Sponsors
Wellcome Trust
Health Service Executive, Ireland
Health Research Board, Ireland
University College Cork
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Months
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Severity of atopic dermatitis in cases as assessed using SCORAD (SCORing Atopic Dermatitis) | 6 months to 12 months | Measured using standardized clinical assessment score (SCORAD) |
| Severity of atopic dermatitis in cases as assessed using the Eczema Area and Severity Index (EASI) | 6 months to 12 months | Measured using standardized clinical assessment score (EASI) |
| Severity of atopic dermatitis in cases as assessed using Investigator's Global Assessment scale (IGA) | 6 months to 12 months | Measured using standardized clinical assessment scores (IGA) |
| Neurodevelopmental assessment | At 18 months of age (one-off assessment) | Measured using novel touchscreen app ('Cognitot') |
Countries
Ireland
Contacts
Primary ContactCathal O'Connor, MD
Outcome results
None listed