Atopic DermatitisDECODE-ScratchNCT06448689
Analytical Validation of Wrist-Based Assessment of Nocturnal Scratch in Atopic Dermatitis and Psoriasis
An observational study of Atopic Dermatitis and Psoriasis, run by ActiGraph L.L.C at 1 site in France.
Trial summary
Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Atopic Dermatitis, Psoriasis
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2024to Jun 2026
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female subjects, aged 14-70 years old, with active atopic dermatitis or psoriasis
Who may be able to join
- At least 14 years old
- Less than 70 years old
- Clinical diagnosis of Atopic Dermatitis
- Peak Pruritis NRS score > 1
- At least 18 years old
- Less than 70 years old
Show all 9Show fewer
- Clinical diagnosis of plaque psoriasis
- At least a peak pruritis PNRS of 4
- Itch is caused by psoriasis, as determined by clinician
Who cannot join
- Non-Atopic Dermatitis or Psoriasis-related sleep disorder (e.g., diagnosed sleep apnea, restless leg syndrome etc...)
- Movement disorder
- Flare or infection on the wrist
- Infected atopic dermatitis or psoriasis lesions
- Pregnant or lactating women
- Shift workers or participants with jetlag
- Current diagnosis of depression
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance
Paris, 75001
Damien Leger, MD
About this study
Official title: Prospective, Hybrid, Single-Center, Single-Arm Study to Characterize Sleep and Scratching Behavior in Adolescents and Adults With Atopic Dermatitis and Adults With Psoriasis
Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life. However, nocturnal scratch behavior and sleep impairment are poorly understood due to the difficulties in quantifying these symptoms in patients' daily lives. This study deploys multiple technologies (polysomnography, video capture, wrist sensors, clinician-reported outcomes, and patient-reported outcomes) to develop and validate a wrist-based solution to quantify nocturnal scratch.
- Conditions
- Atopic Dermatitis, Psoriasis
- Keywords
- nocturnal scratch, itch, validation, sleep impairment, pruritis
- Medical subject headings
- Dermatitis, Atopic, Psoriasis, Pruritus
What is being measured
The primary outcome is the main question the study is designed to answer.
Scratch Movements
To evaluate the agreement in the detection of scratching behaviour between video annotation and wrist-based sensor
Measured: 14 days
Sleep Time
To evaluate the agreement in the detection of sleep patterns between polysomnography and wrist-based sensor
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start12 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
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.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ActiGraph L.L.C
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Damien Leger, Principal investigator, Université Paris Cité, VIFASOM, ERC 7330, Paris, France;b AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448689
- Sponsor's protocol ID
- AG0001
- Acronym
- DECODE-Scratch
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Hybrid, Single-Center, Single-Arm Study to Characterize Sleep and Scratching Behavior in Adolescents and Adults With Atopic Dermatitis and Adults With Psoriasis
- ClinicalTrials.gov ID
- NCT06448689
- Acronym / sponsor ID
- DECODE-Scratch / AG0001
- Conditions
- Atopic Dermatitis, Psoriasis
- Keywords
- nocturnal scratch, itch, validation, sleep impairment, pruritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ActiGraph L.L.CIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Jun 2024 (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.
Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life. However, nocturnal scratch behavior and sleep impairment are poorly understood due to the difficulties in quantifying these symptoms in patients' daily lives. This study deploys multiple technologies (polysomnography, video capture, wrist sensors, clinician-reported outcomes, and patient-reported outcomes) to develop and validate a wrist-based solution to quantify nocturnal scratch.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female subjects, aged 14-70 years old, with active atopic dermatitis or psoriasis
Key inclusion criteria (9 listed)
- At least 14 years old
- Less than 70 years old
- Clinical diagnosis of Atopic Dermatitis
- Peak Pruritis NRS score > 1
- At least 18 years old
Key exclusion criteria (7 listed)
- Non-Atopic Dermatitis or Psoriasis-related sleep disorder (e.g., diagnosed sleep apnea, restless leg syndrome etc...)
- Movement disorder
- Flare or infection on the wrist
- Infected atopic dermatitis or psoriasis lesions
- Pregnant or lactating women
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
Scratch Movements
Time frame: 14 days
To evaluate the agreement in the detection of scratching behaviour between video annotation and wrist-based sensor
Sleep Time
Time frame: 14 days
To evaluate the agreement in the detection of sleep patterns between polysomnography and wrist-based sensor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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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.
Damien Leger principal investigator
Université Paris Cité, VIFASOM, ERC 7330, Paris, France;b AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance, Paris, France
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 Psoriasis, run by ActiGraph L.L.C at 1 site in France.
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 9 inclusion and 7 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 7 Jun 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 France. 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 Sylvain Zorman, PhD (850.332.7900, info@theactigraph.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scratch Movements (time frame: 14 days). 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?
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 7 Jun 2024.