PainMoNOLogNCT04581642
Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report
An observational study of Pain and Opioid Use, run by Medasense Biometrics Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Opioid Use, Dementia
- What is being tested?
- PMD200
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2020to 30 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a clinical syndrome due to disease of a progressive nature, which leads to disturbances in multiple higher cortical functions, including memory, thinking, orientation, comprehension, calculation, learning capacity, language and judgment; 1. Older adults with advanced dementia; 2. Critically ill/unconscious patients; 3. Patients at the end of life stage. 4. Ventilated patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report: An Exploratory, Prospective, Unblinded, Single-center Study- The MoNOLog Study
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.
- Conditions
- Pain, Opioid Use, Dementia, Unconscious, Ventilator Lung
- Being tested
- PMD200
- Medical subject headings
- Pain, Dementia, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMD200Device
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy outcome
To identify what information is currently elicited and used by clinicians when detecting and managing pain.
Measured: 5 months
Efficacy outcome
To assess the feasibility of the current NOL algorithm (PMD200 vs. NOLedge) for pain management in the study population.
Measured: 5 months
Efficacy outcome
To collect data to improve the performance of the NOL algorithm in the study population
Measured: 5 months
Efficacy outcome
The ability of the NOL index to discriminate between periods of painful and non-painful periods
Measured: 10 months
Secondary outcomes (1)
Efficacy outcome
NOL-index performance to detect pain in comparison to PAINAD, BPS pain scores
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Nov 2020
- Primary completion30 Aug 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medasense Biometrics Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adi Sasson, Dr., Principal investigator, DOROT, Netanya Geriatric Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581642
- Sponsor's protocol ID
- CLI-01-1-09
- Acronym
- MoNOLog
- Status last verified
- Dec 2021
- First submitted
- 3 Oct 2020
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nociception-Level (NOL) for the Assessment of Pain in Patient Unable to Self-Report: An Exploratory, Prospective, Unblinded, Single-center Study- The MoNOLog Study
- ClinicalTrials.gov ID
- NCT04581642
- Acronym / sponsor ID
- MoNOLog / CLI-01-1-09
- Conditions
- Pain, Opioid Use, Dementia, Unconscious, Ventilator Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medasense Biometrics LtdUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 9 Oct 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical syndrome due to disease of a progressive nature, which leads to disturbances in multiple higher cortical functions, including memory, thinking, orientation, comprehension, calculation, learning capacity, language and judgment; 1. Older adults with advanced dementia; 2. Critically ill/unconscious patients; 3. Patients at the end of life stage. 4. Ventilated patients.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| PMD200The 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) | Device | – |
Primary outcome
Efficacy outcome
Time frame: 5 months
To identify what information is currently elicited and used by clinicians when detecting and managing pain.
Efficacy outcome
Time frame: 5 months
To assess the feasibility of the current NOL algorithm (PMD200 vs. NOLedge) for pain management in the study population.
Efficacy outcome
Time frame: 5 months
To collect data to improve the performance of the NOL algorithm in the study population
Efficacy outcome
Time frame: 10 months
The ability of the NOL index to discriminate between periods of painful and non-painful periods
1 secondary outcome
Efficacy outcome
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Adi Sasson, Dr. principal investigator
DOROT, Netanya Geriatric Medical Center
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 Pain and Opioid Use, run by Medasense Biometrics Ltd at 1 site in Israel.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 14 Dec 2021. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy outcome (time frame: 5 months). The study lists 4 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 14 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.