Atopic DermatitisNCT05467046
Clinical Relevance of Scratching and Sleep in Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial summary
Atopic Dermatitis (AD), otherwise known as (atopic) eczema, is a chronic relapsing inflammatory skin disease. For difficult-to-treat AD, treatment options are limited. A better understanding of the underlying immunological cause, led to development of new, targeted therapies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Smartwatch system
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Aug 2022to 7 Dec 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The atopic dermatitis patients are recruited at the dermatology outpatient clinic of an academic medical center (University Medical Center Utrecht).
Who may be able to join
- Patient has signed informed consent for the BioDay registry and is enrolled in the BioDay registry.
- Patient has a diagnosis of moderate to severe Atopic Dermatitis, and therefore will be treated with advanced systemic treatment in daily practice according to the Dutch AD guideline (after treatment failure of at least 1 oral immunosuppressive drug or a contra-indication for oral immunosuppressive drugs).
- Patient has no concomitant immunosuppressive therapy at baseline
- Age between 18 and 65 years old (18 years ≤ Age ≤ 65 years).
- Intact skin at both wrists (definition of intact skin: Skin in which there are no breaks, scrapes, cuts, or abnormal openings that allow pathogens to enter).
- Willing and able to provide written informed consent and participate in study procedures.
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- Able to understand, read and write Dutch.
- HCP is allowed to treat AD-patients
- HCP is (trainee) dermatologist, (trainee) physician, (trainee) research-physician, (trainee) nurse practitioner, (trainee) physician assistant or similar, working in the field of dermatology
- HCP has (digitally) signed consent form for the focus group
- HCP works in a hospital that is a member of the BioDay consortium.
Who cannot join
- Unable to understand instructions
- Expected participation of less than 5 weeks
- Travelling or holiday, for 1 night or more, outside the Netherlands during participation in the study.
- Eczema lesions on one or both wrists at study recruitment
- Patients with neurological disease (e.g., Parkinson's Disease) or physical disability affecting one or both hands, wrist and/or arms.
- Irregular or affected sleep/wake pattern due to causes other than AD. (For example: medical conditions like sleep-apnea or primary insomnia, concomitant medication affecting sleep, alternating shift workers or AD-patients with young infants.)
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- Having a tattoo on the upper side of one or both wrists. (Tattoos in the wrist area can cause inaccurate measurements.)
- Institutionalized patients (e.g., care home residents)
- Prisoners (general inmates of prisons or other state institutions)
- Philips research employees
- Study site employees or any other research team member involved directly or indirectly in the conduct of the clinical study
- Cognitively impaired (diagnosis of cognitive impairment in medical file)
- Pregnant persons will not be considered for this study (during pregnancy, the treatment with advanced systemic treatment is not always possible)
- If a patient is not allowed to visit the hospital due to the prevailing COVID-19 restrictions. (If COVID-19 restrictions indicate that it is not allowed to visit the hospital for example when having a positive COVID-19 test, then the patient cannot be included in the study, because it cannot comply with the BioDay study protocol, and thereby indirectly also not with the AD-study protocol).
- For dermatology HCPs the eligibility criteria are:
- Unable or unwilling to attend focus group
- Philips Research employees
Trial locations and contacts
1 site in 1 country.
About this study
Atopic Dermatitis (AD), otherwise known as (atopic) eczema, is a chronic relapsing inflammatory skin disease. For difficult-to-treat AD, treatment options are limited. A better understanding of the underlying immunological cause, led to development of new, targeted therapies. For evaluating effectiveness and making treatment decisions for these new therapies, only 2 subjective methods exist: 1. clinical scores (AD-severity scored by a physician using structured scoring system), 2. questionnaires (completed by AD-patients). Therefore, an objective AD-severity assessment method might provide benefits for clinical practice.
In this study, it is evaluated whether scratching and sleep parameters, obtained with a smartwatch worn by AD-patients, provide added value for clinical practice in dermatology. The usability of this smartwatch system is evaluated by AD-patients.
Read the detailed description
The study consists of two consecutive parts. In part 1, 30 AD-patient will be asked to wear a smartwatch during nighttime and to complete questionnaires regarding the usability of the smartwatch system. In part 2, a focus group with dermatology Health Care Practitioners (HCPs) will take place. In this focus group, the HCPs will evaluate whether the scratching and sleep parameters obtained from the smartwatches worn by the AD-patients in part 1, provide added value for clinical practice in dermatology.
The primary objective is to collect insights in whether objectification of scratching and sleep in AD-patients during the night provides added value for clinical practice in dermatology. The secondary objective is to collect insights into the requirements of AD-patients and dermatology HCPs for a smartwatch system to be acceptable for use in the dermatology clinical practice.
- Conditions
- Atopic Dermatitis
- Being tested
- Smartwatch system
- Keywords
- Atopic dermatitis, Scratching, Sleep
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartwatch systemDevice
The Atopic Dermatitis patient cohort is exposed to using a smartwatch system for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AD-patients | Not described Receives: Device: Smartwatch system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback from dermatology HCPs on whether objectification of nighttime scratching and sleep in AD-patients provides added value for clinical practice in dermatology.
Measured: 1 hour, after completion of study part 1
Secondary outcomes (3)
AD-Patient participant feedback via a questionnaire (usability schale) on the acceptability and usability of a wearable-solution for AD-patients.
Measured: baseline, and after 5 weeks of participation
Nighttime sleep quality measured with a smartwatch.
The following specific sleep quality parameters will be collected, amongst others, Total Sleep Time, Wake After Sleep Onset, Number of Awakenings
Measured: baseline, and after 5 weeks of participation
Nighttime scratching parameters (e.g., number and duration of scratching periods) determined with a smartwatch.
Measured: baseline, and after 5 weeks of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start3 Aug 2022
- Primary completion30 Sep 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Marjolein de Buin-Weller, MD, PhD, Principal investigator, University Medical Center Utrecht (UMC Utrecht)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467046
- Sponsor's protocol ID
- ICBE-S-000319
- Status last verified
- Apr 2024
- First submitted
- 7 Jul 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Scratching and Sleep in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05467046
- Acronym / sponsor ID
- ICBE-S-000319
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Scratching, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 20 Jul 2022 (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.
Atopic Dermatitis (AD), otherwise known as (atopic) eczema, is a chronic relapsing inflammatory skin disease. For difficult-to-treat AD, treatment options are limited. A better understanding of the underlying immunological cause, led to development of new, targeted therapies. For evaluating effectiveness and making treatment decisions for these new therapies, only 2 subjective methods exist: 1. clinical scores (AD-severity scored by a physician using structured scoring system), 2. questionnaires (completed by AD-patients). Therefore, an objective AD-severity assessment method might provide benefits for clinical practice.
In this study, it is evaluated whether scratching and sleep parameters, obtained with a smartwatch worn by AD-patients, provide added value for clinical practice in dermatology. The usability of this smartwatch system is evaluated by AD-patients.
Detailed description
The study consists of two consecutive parts. In part 1, 30 AD-patient will be asked to wear a smartwatch during nighttime and to complete questionnaires regarding the usability of the smartwatch system. In part 2, a focus group with dermatology Health Care Practitioners (HCPs) will take place. In this focus group, the HCPs will evaluate whether the scratching and sleep parameters obtained from the smartwatches worn by the AD-patients in part 1, provide added value for clinical practice in dermatology.
The primary objective is to collect insights in whether objectification of scratching and sleep in AD-patients during the night provides added value for clinical practice in dermatology. The secondary objective is to collect insights into the requirements of AD-patients and dermatology HCPs for a smartwatch system to be acceptable for use in the dermatology clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD-patients | – | Device: Smartwatch system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The atopic dermatitis patients are recruited at the dermatology outpatient clinic of an academic medical center (University Medical Center Utrecht).
Key inclusion criteria (11 listed)
- Patient has signed informed consent for the BioDay registry and is enrolled in the BioDay registry.
- Patient has a diagnosis of moderate to severe Atopic Dermatitis, and therefore will be treated with advanced systemic treatment in daily practice according to the Dutch AD guideline (after treatment failure of at least 1 oral immunosuppressive drug or a contra-indication for oral immunosuppressive drugs).
- Patient has no concomitant immunosuppressive therapy at baseline
- Age between 18 and 65 years old (18 years ≤ Age ≤ 65 years).
- Intact skin at both wrists (definition of intact skin: Skin in which there are no breaks, scrapes, cuts, or abnormal openings that allow pathogens to enter).
Key exclusion criteria (17 listed)
- Unable to understand instructions
- Expected participation of less than 5 weeks
- Travelling or holiday, for 1 night or more, outside the Netherlands during participation in the study.
- Eczema lesions on one or both wrists at study recruitment
- Patients with neurological disease (e.g., Parkinson's Disease) or physical disability affecting one or both hands, wrist and/or arms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartwatch systemThe Atopic Dermatitis patient cohort is exposed to using a smartwatch system for 5 weeks. | Device | AD-patients |
Primary outcome
Feedback from dermatology HCPs on whether objectification of nighttime scratching and sleep in AD-patients provides added value for clinical practice in dermatology.
Time frame: 1 hour, after completion of study part 1
3 secondary outcomes
AD-Patient participant feedback via a questionnaire (usability schale) on the acceptability and usability of a wearable-solution for AD-patients.
Time frame: baseline, and after 5 weeks of participation
Nighttime sleep quality measured with a smartwatch.
Time frame: baseline, and after 5 weeks of participation
Nighttime scratching parameters (e.g., number and duration of scratching periods) determined with a smartwatch.
Time frame: baseline, and after 5 weeks of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Marjolein de Buin-Weller, MD, PhD principal investigator
University Medical Center Utrecht (UMC Utrecht)
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, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
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 11 inclusion and 17 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: finished, as of the sponsor's last update on 3 Apr 2024. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feedback from dermatology HCPs on whether objectification of nighttime scratching and sleep in AD-patients provides added value for clinical practice in dermatology. (time frame: 1 hour, after completion of study part 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2024.