Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT06677593
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2024-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Electrodermal Activity in Pain 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2024-11-01', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'while participants wear the device (up to 7 days)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Skin conductance level', 'timeFrame': 'while participants wear the device (up to 7 days)', 'description': 'The average skin conductance value (μS) for 10 seconds.'}, {'measure': 'Number of Skin Conductance Fluctuations', 'timeFrame': 'while participants wear the device (up to 7 days)', 'description': 'Peaks with minimum amplitudes of 0.02 μS and a slope rate \\< 2 μS/s, in 10 second intervals'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'administered the day of enrollment', 'description': 'The Patient Health Questionnaire (PHQ-9) will be used to screen participants as symptoms of depression in order to control during the statistical analysis.\n\nThe 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.'}, {'measure': 'Pain frequency', 'timeFrame': 'while participants wear the device (up to a period of 7 days)', 'description': 'Number of patient reported pain episodes of pain intensity over 5 (using the NRS pain intensity scale)'}, {'measure': 'Pain evaluation from healthcare personale not possible', 'timeFrame': 'in the duration that the participant wears the device (up to 7 days)', 'description': '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.'}, {'measure': 'Medication list', 'timeFrame': 'while participants wear the device (up to 7 days)', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'electrodermal activity', 'pain detection', 'pain prediction', 'galvanic skin response', 'wearable', 'pain monitoring'], 'conditions': ['Cancer', 'Chronic Obstructive Pulmonary Disease (COPD', 'Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nHypothesis: Electrodermal activity can distinguish different pain intensity levels in patients with chronic pain and a life-threatening disease.\n\nMethodology: 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.\n\nAnalysis: 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.', 'detailedDescription': 'Methods The study is a phase 2 trial, preceded by a phase 1 trial that included healthy volunteers.\n\nPatients will be inpatients and outpatients at Department of Pulmonary and Endocrine Diseases, Hvidovre Hospital.\n\nMeasures 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.\n\nPatient 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.\n\nAmbulatory 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.\n\nObjective measures Electrodermal activity. A wearable device provided by Movisens GmbH will be used to record skin conductance measured in microsiemens (μS).\n\nWearable 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hvidovre Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Danish\n* Age over 18\n* Persistent or recurrent pain (longer than three months)\n* Cancer: DC01-DC9 or Pulmonary Diseases:DJ40-DJ47\n\nExclusion Criteria:\n\n* A current diagnosis with psychological/ psychiatric disorders\n* Impaired cognitive function\n* Substance abuse\n* A skin condition on the to-be-tested body parts\n* PHQ-9 reveals suicidal ideation'}, 'identificationModule': {'nctId': 'NCT06677593', 'acronym': 'DEEP 2', 'briefTitle': 'Detection of Electrodermal Activity in Pain 2', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'Detection of Electrodermal Activity in Pain (DEEP)', 'orgStudyIdInfo': {'id': 'H-24037808-Phase-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with COPD or cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Faidra Papanikolaou, MSc, MEng', 'role': 'CONTACT', 'email': 'faidra.papanikolaou@regionh.dk'}, {'name': 'Kirstine S Benthien, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Copenhagen University Hospital - Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Kirstine S Benthien, PhD', 'role': 'CONTACT', 'email': 'kirstine.skov.benthien.01@regionh.dk', 'phone': '+45 21 59 65 92'}, {'name': 'Faidra Papanikolaou, MSc, MEng', 'role': 'CONTACT', 'email': 'faidra.papanikolaou@regionh.dk'}], 'overallOfficials': [{'name': 'Kirstine S Benthien, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kirstine Skov Benthien', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}