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RecruitingNCT07909967Updated Nov 4, 2026

Observational Analytical Validation Study of the Replior ScratchSense

An observational study in Atopic Dermatitis, Pruritus and Chronic Pruritus of Unknown Origin, sponsored by Replior AB. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Replior AB · Observational

Updated Nov 4, 2026Primary outcomes revisedStudy contact changed+1 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
35
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

Sleep tracking as secondary objective. Replior ScratchSense ring (scratch and sleep research tracking)

02

Conditions studied

  • Atopic Dermatitis
  • Pruritus
  • Chronic Pruritus of Unknown Origin

Keywords

  • Scratch
  • Sleep
  • Sensor
  • Wireless
  • Nocturnal Scratch
  • Sleep disorders
  • Sleep Time Opportunity
03

In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's planned enrollment of 35 is below the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

This is the only study on the registry with Replior AB as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male / female participant, aged 18 to 65 years inclusive. Negative pregnancy test at screening for 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

Exclusion criteria

Exclusion Criteria:

  • 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 ii. 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
35 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Device: Scratch and sleep research tracking

Interventions

  • DeviceScratch and sleep research tracking

    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.

06

What researchers measure

Primary outcomes

  1. Number of Scratch bout

    Scratch Bout: a group of one or more Scratch Events occurring in close temporal proximity.

    Time frame: From enrollment to Night 3 (Visit3)

Secondary outcomes

  1. Total Sleep Time (TST)

    Minutes of sleep across the night; the total minutes actually spent asleep during the night.

    Time frame: From enrollment to Night 3

07

Study locations

1 of 1 sites recruiting
  • Eurofins Optimed 1 rue des Essarts, 38610 Gières - France
    Grenoble, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Scratch boat measurementsNow Number of Scratch boutTime frame: From enrollment to Night 3 (Visit3)
Nov 4, 2026
Secondary outcomes
1 added
What changed in the outcomes
  • AddedTotal Sleep Time (TST)Time frame: From enrollment to Night 3
Nov 4, 2026
Contact
Study contact changed: c•••@repiior.se · •••6689→c•••@replior.se · •••6689. See the current contact
Nov 4, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 4, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Scratch boat measurementsNow Number of Scratch boutTime frame: From enrollment to Night 3 (Visit3)
    Secondary outcomes 1 added
    What changed in the outcomes
    • AddedTotal Sleep Time (TST)Time frame: From enrollment to Night 3
    Contact Study contact changed: c•••@repiior.se · •••6689→c•••@replior.se · •••6689. See the current contact
    + 5 other changes: index terms, verification date, description, conditions and criteria formatting
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07909967
Lead sponsor
Replior AB
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Oct 12, 2026
Primary completion
Dec 10, 2026 (estimated)
Completion
Dec 11, 2026 (estimated)
Last update
Nov 4, 2026

Study contacts

Christer Nilsson Study Director
Contact
christer.nilsson@replior.se
+46 706956689
Christer Nilsson
study director · Replior AB

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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