Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation (SPINDLE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance; Atopic Dermatitis

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Cathal O'Connor, MD; Phone Number: +353877919176; Email: cathal.oconnor@ucc.ie

Study Locations

• Ireland
  • Cork, Ireland
    • Recruiting
    • INFANT
    • Contact: Cathal O'Connor, MD; Phone Number: 0877919176; Email: cathal.oconnor@ucc.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Infants with atopic dermatitis
Infants without atopic dermatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Measured using standardized questionnaire (PSQI)	6 months to 12 months

Other Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: University College Cork
• Collaborators: Wellcome Trust; Health Research Board, Ireland; Health Service Executive, Ireland
• Investigators: Principal Investigator: Geraldine Boylan, PhD, INFANT, University College Cork

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Skin Diseases; Immune System Diseases; Sleep Wake Disorders; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dyssomnias; Parasomnias; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 223047/Z/21/Z

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No