Atopic DermatitisNCT07909967
Observational Analytical Validation Study of the Replior ScratchSense
An observational study of Atopic Dermatitis and Other Pruritic Dermatological, run by Replior AB at 1 site in France.
Trial summary
Nocturnal scratching is a frequent and meaningful symptom in dermatological conditions such as atopic dermatitis. It may reflect underlying disease activity and can substantially disrupt overall sleep and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis, Other Pruritic Dermatological, Chronic Pruritus of Unknown Origin
- What is being tested?
- Scratch and sleep research tracking
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2026to 11 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Willing and able to wear two finger-worn sensors, one on each hand (on the index or middle finger), during sleep for three nights. Willing to undergo a video recording using thermal camera overnight in a controlled environment during sleep for three nights. Willing to wear the PSG system during sleep as part of the protocol during sleep for three nights. Able and willing to follow all study instructions, including completing questionnaires and attending study visits. Written informed consent signed prior to selection, included specific thermal video recording consent.
Who may be able to join
- Male / female participant, aged 18 to 65 years inclusive. Negative pregnancy test at screening for childbearing potential women. Presence of itch-related and/or scratching-inducing conditions: documented or self-reported history of nocturnal itching and scratching, due to conditions such as:
- Atopic dermatitis
- Chronic pruritus of unknown origin
- Other pruritic dermatological or systemic conditions. Expected Nocturnal Scratch activity: participants must: Have experienced Nocturnal Scratching in the past 7 days, and
- Be considered likely to scratch during the study period, based on medical history, clinician judgment, or recent self-report
Who cannot join
- No current or expected nocturnal itch: well-controlled conditions or no recent reports of nighttime scratching. Confounding movement disorders or sleep conditions: diagnosed restless legs syndrome, periodic limb movement disorder, moderate/severe obstructive sleep apnea, Parkinson's disease, or other conditions that may interfere with motion analysis. Recent changes in anti-pruritic treatment: Initiation or dose changes of systemic medications that may suppress nocturnal itch within the past 2 weeks, including: i. Oral corticosteroids ii. Immunosuppressive agents (e.g., cyclosporine, methotrexate) iii. Biologics (e.g., dupilumab) unless on a stable dose ≥8 weeks iv. Sedating antihistamines unless stable for ≥1 week. Topical treatment use: initiation of topical corticosteroids, calcineurin inhibitors, or emollients within 3 days prior to study start, and no use during the study. Severe psychiatric or cognitive impairment that could impair the ability to consent or comply with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Eurofins Optimed 1 rue des Essarts, 38610 Gières - France
Grenoble
About this study
Official title: Observational Analytical Validation Study of the Replior ScratchSense for Nocturnal Scratching Assessment
Nocturnal scratching is a frequent and meaningful symptom in dermatological conditions such as atopic dermatitis. It may reflect underlying disease activity and can substantially disrupt overall sleep and quality of life. Existing approaches to characterizing Nocturnal Scratching-such as self-reports, sleep diaries, and video monitoring-are often subjective, labor-intensive, or lack scalability for widespread use.
Emerging wearable technologies offer an alternative, by enabling objective, continuous, and non- invasive signal related to scratch behavior during sleep.
Read the detailed description
The primary objective of this analytical validation study is to evaluate the characteristics of the Replior ScratchSense designed to detect and quantify Nocturnal Scratch behavior in users. This includes validating the accuracy, precision, specificity, and overall reliability of the ring's scratch detection algorithm in a controlled environment.
- Being tested
- Scratch and sleep research tracking
- Keywords
- Scratch, Sleep, Sensor, Wireless, Nocturnal Scratch, Sleep disorders, Sleep Time Opportunity
- Medical subject headings
- Dermatitis, Atopic, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scratch and sleep research trackingDevice
Replior ScratchSense finger worn sensor in detecting and characterizing nocturnal scratching through motion and contact vibration signals and collecting signals associated with sleep related movement patterns and scratch-related intensity and pressure.
| Study group | Role | What they receive |
|---|---|---|
| Sensor wearing | Concerning Nocturnal Scratch, each participant will be equipped with two Replior ScratchSense rings, worn on the index or middle finger of each hand Receives: Device: Scratch and sleep research tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scratch boat measurements
Scratch Bout: a group of one or more Scratch Events occurring in close temporal proximity.
Measured: From enrollment to Night 3 (Visit3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start12 Oct 2026
- Primary completion10 Dec 2026 (estimated)
- Study completion11 Dec 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
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Replior AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christer Nilsson, Study director, Replior AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909967
- Sponsor's protocol ID
- OP115126.REP
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Analytical Validation Study of the Replior ScratchSense for Nocturnal Scratching Assessment
- ClinicalTrials.gov ID
- NCT07909967
- Acronym / sponsor ID
- OP115126.REP
- Keywords
- Scratch, Sleep, Sensor, Wireless, Nocturnal Scratch, Sleep disorders, Sleep Time Opportunity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Replior ABIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2026 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 2 Nov 2026 (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.
Nocturnal scratching is a frequent and meaningful symptom in dermatological conditions such as atopic dermatitis. It may reflect underlying disease activity and can substantially disrupt overall sleep and quality of life. Existing approaches to characterizing Nocturnal Scratching-such as self-reports, sleep diaries, and video monitoring-are often subjective, labor-intensive, or lack scalability for widespread use.
Emerging wearable technologies offer an alternative, by enabling objective, continuous, and non- invasive signal related to scratch behavior during sleep.
Detailed description
The primary objective of this analytical validation study is to evaluate the characteristics of the Replior ScratchSense designed to detect and quantify Nocturnal Scratch behavior in users. This includes validating the accuracy, precision, specificity, and overall reliability of the ring's scratch detection algorithm in a controlled environment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensor wearing | – | Device: Scratch and sleep research trackingConcerning Nocturnal Scratch, each participant will be equipped with two Replior ScratchSense rings, worn on the index or middle finger of each hand |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Willing and able to wear two finger-worn sensors, one on each hand (on the index or middle finger), during sleep for three nights. Willing to undergo a video recording using thermal camera overnight in a controlled environment during sleep for three nights. Willing to wear the PSG system during sleep as part of the protocol during sleep for three nights. Able and willing to follow all study instructions, including completing questionnaires and attending study visits. Written informed consent signed prior to selection, included specific thermal video recording consent.
Key inclusion criteria (5 listed)
- Male / female participant, aged 18 to 65 years inclusive. Negative pregnancy test at screening for childbearing potential women. Presence of itch-related and/or scratching-inducing conditions: documented or self-reported history of nocturnal itching and scratching, due to conditions such as:
Key exclusion criteria (1 listed)
- No current or expected nocturnal itch: well-controlled conditions or no recent reports of nighttime scratching. Confounding movement disorders or sleep conditions: diagnosed restless legs syndrome, periodic limb movement disorder, moderate/severe obstructive sleep apnea, Parkinson's disease, or other conditions that may interfere with motion analysis. Recent changes in anti-pruritic treatment: Initiation or dose changes of systemic medications that may suppress nocturnal itch within the past 2 weeks, including: i. Oral corticosteroids ii. Immunosuppressive agents (e.g., cyclosporine, methotrexate) iii. Biologics (e.g., dupilumab) unless on a stable dose ≥8 weeks iv. Sedating antihistamines unless stable for ≥1 week. Topical treatment use: initiation of topical corticosteroids, calcineurin inhibitors, or emollients within 3 days prior to study start, and no use during the study. Severe psychiatric or cognitive impairment that could impair the ability to consent or comply with the protocol
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 |
|---|---|---|
| Scratch and sleep research trackingReplior ScratchSense finger worn sensor in detecting and characterizing nocturnal scratching through motion and contact vibration signals and collecting signals associated with sleep related movement patterns and scratch-related intensity and pressure. | Device | Sensor wearing |
Primary outcome
Scratch boat measurements
Time frame: From enrollment to Night 3 (Visit3)
Scratch Bout: a group of one or more Scratch Events occurring in close temporal proximity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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.
Christer Nilsson study director
Replior AB
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 Other Pruritic Dermatological, run by Replior AB 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christer Nilssen Study Director (+46 706956689, christer.nilsson@repiior.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scratch boat measurements (time frame: From enrollment to Night 3 (Visit3)). 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 2 Nov 2026.