CancerDEEP 2NCT06677593
Detection of Electrodermal Activity in Pain 2
An observational study of Cancer and Chronic Obstructive Pulmonary Disease (COPD, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
The goal of this study is to investigate the association between self-reported pain and electrodermal activity and to create an algorithm that detects pain and provides timely alarms for rising pain levels in patients with life-threatening illnesses suffering from persistent pain. The study is exploratory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chronic Obstructive Pulmonary Disease (COPD, Pain
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2024to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hvidovre Hospital
Who may be able to join
- Danish
- Age over 18
- Persistent or recurrent pain (longer than three months)
- Cancer: DC01-DC9 or Pulmonary Diseases:DJ40-DJ47
Who cannot join
- A current diagnosis with psychological/ psychiatric disorders
- Impaired cognitive function
- Substance abuse
- A skin condition on the to-be-tested body parts
- PHQ-9 reveals suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Electrodermal Activity in Pain (DEEP)
The goal of this study is to investigate the association between self-reported pain and electrodermal activity and to create an algorithm that detects pain and provides timely alarms for rising pain levels in patients with life-threatening illnesses suffering from persistent pain. The study is exploratory.
Hypothesis: Electrodermal activity can distinguish different pain intensity levels in patients with chronic pain and a life-threatening disease.
Read more
Methodology: Thirty-seven patients with cancer and/or chronic obstructive pulmonary disease (COPD) will be identified through hospital record screening. These patients will wear a monitoring device for a maximum of one week and report their pain intensity throughout the day.
Analysis: Discriminant analysis will be used to differentiate between mild, moderate, and severe pain. This study is exploratory, generating hypotheses for subsequent phases of the project.
Read the detailed description
Methods The study is a phase 2 trial, preceded by a phase 1 trial that included healthy volunteers.
Patients will be inpatients and outpatients at Department of Pulmonary and Endocrine Diseases, Hvidovre Hospital.
Measures Subjective measures (self reported) Pain. Pain intensity (interval, 0 to 10) is measured using the NRS, a commonly used tool asking patients to rate their pain intensity on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.
Patient Health Status. The Patient Health Questionnaire (PHQ-9) is used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. The PHQ-9 is the depression module.
Ambulatory assessment. The patient group in phase 2 will be asked to wear a wristband device for 1 week. During this period, a prompt will be sent on a smartphone connected to a wearable device provided by Movisens GmbH, five times a day (9 am, 12 pm, 3 pm, 6 pm, and 9 pm) to answer questions about their current pain levels using the NRS scale.
Objective measures Electrodermal activity. A wearable device provided by Movisens GmbH will be used to record skin conductance measured in microsiemens (μS).
Wearable device The EdaMove 4 device provided by Movisens GmbH consists of an EDA and activity sensor. It records EDA signals to monitor both tonic and phasic electrical activity in the skin.
- Conditions
- Cancer, Chronic Obstructive Pulmonary Disease (COPD, Pain
- Keywords
- pain, electrodermal activity, pain detection, pain prediction, galvanic skin response, wearable, pain monitoring
- Medical subject headings
- Neoplasms, Pulmonary Disease, Chronic Obstructive, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with COPD or cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Numerical rating scale score. Pain intensity (interval, 0 to 10) is measured using the NRS, a commonly used tool asking patients to rate their pain intensity on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.
Measured: while participants wear the device (up to 7 days)
Secondary outcomes (6)
Skin conductance level
The average skin conductance value (μS) for 10 seconds.
Measured: while participants wear the device (up to 7 days)
Number of Skin Conductance Fluctuations
Peaks with minimum amplitudes of 0.02 μS and a slope rate < 2 μS/s, in 10 second intervals
Measured: while participants wear the device (up to 7 days)
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) will be used to screen participants as symptoms of depression in order to control during the statistical analysis.
The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day), providing a 0 to 27 severity score.
Measured: administered the day of enrollment
Pain frequency
Number of patient reported pain episodes of pain intensity over 5 (using the NRS pain intensity scale)
Measured: while participants wear the device (up to a period of 7 days)
Pain evaluation from healthcare personale not possible
Evaluate how often it is not possible to estimate pain levels for patients, thus, a need for a tool to assist). This is marked at the patient journal.
Measured: in the duration that the participant wears the device (up to 7 days)
Medication list
The list of medication a participant takes on regular basis during the week they will be assessed. This data will be collected from the patient journals to control and to understand the final dataset.
Measured: while participants wear the device (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start15 Nov 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Kirstine Skov Benthien, Copenhagen University Hospital, Hvidovre
- Investigators
- Kirstine S Benthien, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677593
- Sponsor's protocol ID
- H-24037808-Phase-2
- Acronym
- DEEP 2
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Electrodermal Activity in Pain (DEEP)
- ClinicalTrials.gov ID
- NCT06677593
- Acronym / sponsor ID
- DEEP 2 / H-24037808-Phase-2
- Conditions
- Cancer, Chronic Obstructive Pulmonary Disease (COPD, Pain
- Keywords
- pain, electrodermal activity, pain detection, pain prediction, galvanic skin response, wearable, pain monitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Nov 2024 (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.
The goal of this study is to investigate the association between self-reported pain and electrodermal activity and to create an algorithm that detects pain and provides timely alarms for rising pain levels in patients with life-threatening illnesses suffering from persistent pain. The study is exploratory.
Hypothesis: Electrodermal activity can distinguish different pain intensity levels in patients with chronic pain and a life-threatening disease.
Methodology: Thirty-seven patients with cancer and/or chronic obstructive pulmonary disease (COPD) will be identified through hospital record screening. These patients will wear a monitoring device for a maximum of one week and report their pain intensity throughout the day.
Analysis: Discriminant analysis will be used to differentiate between mild, moderate, and severe pain. This study is exploratory, generating hypotheses for subsequent phases of the project.
Detailed description
Methods The study is a phase 2 trial, preceded by a phase 1 trial that included healthy volunteers.
Patients will be inpatients and outpatients at Department of Pulmonary and Endocrine Diseases, Hvidovre Hospital.
Measures Subjective measures (self reported) Pain. Pain intensity (interval, 0 to 10) is measured using the NRS, a commonly used tool asking patients to rate their pain intensity on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.
Patient Health Status. The Patient Health Questionnaire (PHQ-9) is used to provisionally diagnose depression and grade severity of symptoms in general medical and mental health settings. The PHQ-9 is the depression module.
Ambulatory assessment. The patient group in phase 2 will be asked to wear a wristband device for 1 week. During this period, a prompt will be sent on a smartphone connected to a wearable device provided by Movisens GmbH, five times a day (9 am, 12 pm, 3 pm, 6 pm, and 9 pm) to answer questions about their current pain levels using the NRS scale.
Objective measures Electrodermal activity. A wearable device provided by Movisens GmbH will be used to record skin conductance measured in microsiemens (μS).
Wearable device The EdaMove 4 device provided by Movisens GmbH consists of an EDA and activity sensor. It records EDA signals to monitor both tonic and phasic electrical activity in the skin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with COPD or cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hvidovre Hospital
Key inclusion criteria (4 listed)
- Danish
- Age over 18
- Persistent or recurrent pain (longer than three months)
- Cancer: DC01-DC9 or Pulmonary Diseases:DJ40-DJ47
Key exclusion criteria (5 listed)
- A current diagnosis with psychological/ psychiatric disorders
- Impaired cognitive function
- Substance abuse
- A skin condition on the to-be-tested body parts
- PHQ-9 reveals suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain intensity
Time frame: while participants wear the device (up to 7 days)
Numerical rating scale score. Pain intensity (interval, 0 to 10) is measured using the NRS, a commonly used tool asking patients to rate their pain intensity on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.
6 secondary outcomes
Skin conductance level
Time frame: while participants wear the device (up to 7 days)
Number of Skin Conductance Fluctuations
Time frame: while participants wear the device (up to 7 days)
Patient Health Questionnaire (PHQ-9)
Time frame: administered the day of enrollment
Pain frequency
Time frame: while participants wear the device (up to a period of 7 days)
Pain evaluation from healthcare personale not possible
Time frame: in the duration that the participant wears the device (up to 7 days)
Medication list
Time frame: while participants wear the device (up to 7 days)
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 19 Mar 2026.
- 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.
Kirstine S Benthien, PhD principal investigator
University of Copenhagen
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 Cancer and Chronic Obstructive Pulmonary Disease (COPD, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 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 Denmark. 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?
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?
Pain intensity (time frame: while participants wear the device (up to 7 days)). 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 19 Mar 2026.