Atopic DermatitisSPINDLENCT05031754
Assessing SleeP IN Infants With Atopic Dermatitis by Longitudinal Evaluation
An observational study of Atopic Dermatitis and Sleep Disturbance, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Sleep Disturbance
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 3 Dec 2020to Jul 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Moderate to severe atopic dermatitis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
INFANT
Cork
Cathal O'Connor, MD, 0877919176, cathal.oconnor@ucc.ie
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopic Dermatitis, Sleep Disturbance
- Medical subject headings
- Dermatitis, Atopic, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants with atopic dermatitis | Infants with atopic dermatitis | |
| Infants without atopic dermatitis | Infants without atopic dermatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered macrostructure of sleep from 6 to 12 months measured with parental sleep diaries
Measured as decreased sleep efficiency and increased night time awakenings
Measured: 6 months to 12 months
Altered macrostructure of sleep at 6 and 12 months measured by nocturnal actigraphy
Measured as sensor-detected movement
Measured: 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
Measured as sleep spindle power and power in rapid eye movement (REM) and non-rapid eye movement (NREM) sleep stages
Measured: 6-8 months
Parental sleep quality and quality of life measured using the Pittsburgh Sleep Quality Index (PSQI)
Measured using standardized questionnaire (PSQI)
Measured: 6 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start3 Dec 2020
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Health Service Executive, Ireland, Health Research Board, Ireland
- Responsible party
- Sponsor
- Investigators
- Geraldine Boylan, PhD, Principal investigator, INFANT, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031754
- Sponsor's protocol ID
- 223047/Z/21/Z
- Acronym
- SPINDLE
- Status last verified
- May 2022
- First submitted
- 20 Aug 2021
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35717147
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing SleeP IN Infants With Early-onset Atopic Dermatitis by Longitudinal Evaluation
- ClinicalTrials.gov ID
- NCT05031754
- Acronym / sponsor ID
- SPINDLE / 223047/Z/21/Z
- Conditions
- Atopic Dermatitis, Sleep Disturbance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Wellcome Trust, Health Service Executive, Ireland, Health Research Board, Ireland
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants with atopic dermatitis | – | –Infants with atopic dermatitis |
| Infants without atopic dermatitis | – | –Infants without atopic dermatitis |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Moderate to severe atopic dermatitis
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Altered macrostructure of sleep from 6 to 12 months measured with parental sleep diaries
Time frame: 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
Time frame: 6 months, 12 months
Measured as sensor-detected movement
2 secondary outcomes
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
Time frame: 6-8 months
Parental sleep quality and quality of life measured using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 35717147O'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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine Boylan, PhD principal investigator
INFANT, University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Sleep Disturbance, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathal O'Connor, MD (+353877919176, cathal.oconnor@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altered macrostructure of sleep from 6 to 12 months measured with parental sleep diaries (time frame: 6 months to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.