Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report

Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report: An Exploratory, Prospective, Unblinded, Single-center Study- The MoNOLog Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04581642

Acronym

MoNOLog

Enrollment

Registered

2020-10-09

Start date

2020-11-01

Completion date

2021-11-30

Last updated

2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Opioid Use, Pain, Unconscious, Ventilator Lung

Brief summary

In this study we aimed to investigate the performance and effectiveness of NOL and/or NOLedge as a tool for pain assessment in geriatric and critical ill non communicating patients. Our hypothesis was that NOL and the NOLedge may have good correlation with the health-care professional assessment PAINAD, BPS values, even with the use of the drugs affecting autonomic nervous system.

Interventions

DEVICEPMD200

The NOL technology is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male and female, Age \> 18 years old. * Spontaneously breathing or mechanically ventilated * Any patient who is unable to express his/her own level of personal pain by using visual scales according to the hospital standard * Written informed consent provided by the participant (if they have capacity) or guardian (if they do not have capacity) or a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant.

Exclusion criteria

* A patient whose staff or research team believes that his or her participation in the research will cause suffering to the patient. * Unstable condition preventing planned routine procedures of care, and conditions precluding the use of PMD-200: absence of sinus cardiac rhythm.

Design outcomes

Primary

Measure	Time frame	Description
Efficacy outcome	5 months	To identify what information is currently elicited and used by clinicians when detecting and managing pain.

Secondary

Measure	Time frame	Description
Efficacy outcome	10 months	NOL-index performance to detect pain in comparison to PAINAD, BPS pain scores

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026