Observational Analytical Validation Study of the Replior ScratchSense

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.

Inclusion Criteria:

• 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

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 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