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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| Health Service Executive, Ireland | OTHER |
| Health Research Board, Ireland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants with atopic dermatitis | Infants with atopic dermatitis | ||
| Infants without atopic dermatitis | Infants without atopic dermatitis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Altered macrostructure of sleep at 6 and 12 months measured by nocturnal actigraphy | Measured as sensor-detected movement | 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Parental sleep quality and quality of life measured using the Pittsburgh Sleep Quality Index (PSQI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Severity of atopic dermatitis in cases as assessed using the Eczema Area and Severity Index (EASI) |
Inclusion Criteria:
- Moderate to severe atopic dermatitis
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathal O'Connor, MD | Contact | +353877919176 | cathal.oconnor@ucc.ie |
| Name | Affiliation | Role |
|---|---|---|
| Geraldine Boylan, PhD | INFANT, University College Cork | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INFANT | Recruiting | Cork | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35717147 | Derived | 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. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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Inflammatory cytokine analysis is being performed by tape stripping.
Measured using standardized questionnaire (PSQI) |
| 6 months to 12 months |
Measured using standardized clinical assessment score (EASI) |
| 6 months to 12 months |
| 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 |
| Neurodevelopmental assessment | Measured using novel touchscreen app ('Cognitot') | At 18 months of age (one-off assessment) |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |