NCT05031754

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2.6 years

First QC Date

August 20, 2021

Last Update Submit

May 26, 2022

Conditions

Atopic DermatitisSleep Disturbance

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

  • Parental sleep quality and quality of life measured using the Pittsburgh Sleep Quality Index (PSQI)

    6 months to 12 months

Other Outcomes (4)

  • Severity of atopic dermatitis in cases as assessed using SCORAD (SCORing Atopic Dermatitis)

    6 months to 12 months

  • Severity of atopic dermatitis in cases as assessed using the Eczema Area and Severity Index (EASI)

    6 months to 12 months

  • Severity of atopic dermatitis in cases as assessed using Investigator's Global Assessment scale (IGA)

    6 months to 12 months

  • +1 more other outcomes

Study Arms (2)

Infants with atopic dermatitis

Infants with atopic dermatitis

Infants without atopic dermatitis

Infants without atopic dermatitis

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • \- Moderate to severe atopic dermatitis

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INFANT

Cork, Ireland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35717147DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Inflammatory cytokine analysis is being performed by tape stripping.

MeSH Terms

Conditions

Dermatitis, AtopicParasomnias

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Geraldine Boylan, PhD

    INFANT, University College Cork

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathal O'Connor, MD

CONTACT

+353877919176cathal.oconnor@ucc.ie

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2021

First Posted

September 2, 2021

Study Start

December 3, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

IE(1)