Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 1:10 PM
Study NCT ID:
NCT05737550
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2023-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'markku.hamalainen@kontigocare.com', 'phone': '+46 (0)76 947 3132', 'title': 'Markku Hämälainen, CSO', 'organization': 'Kontigo Care AB'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 4 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Good', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Manageble', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Less good', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 1. Please evaluate the study subject's ability to use the mobile phone?\n\nResponse options:\n\n* Good\n* Manageable\n* Less good", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Very good', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Good', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Either good or bad', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Difficult', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 2. How did you perceive the study subject's ability to follow the instructions given by Previct Drugs?\n\nResponse options:\n\n* Very good\n* Good\n* Either good or bad\n* Difficult\n* Very difficult", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Very easy', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Easy', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Either easy or difficult', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Difficult', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Very difficult', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 4. How did the study subject experience to put him/herself in the right position to be able to start a test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Very easy', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Easy', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Either easy or difficult', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Difficult', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Very difficult', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 6. How would you evaluate the study subject's ability to perform a Cross-eyes test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Very easy', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Easy', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Either easy or difficult', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Difficult', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Very difficult', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 8. How would you evaluate the study subject's ability to perform a Nystagmus test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Analysis data missing for one subject.'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Very easy', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Easy', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Either easy or difficult', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Difficult', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Very difficult', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 10. How would you evaluate the study subject's ability to perform a Contraction Test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Analysis data missing for one subject.'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Very easy', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Easy', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Either easy or difficult', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Difficult', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Very difficult', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 12. How did the study subject experience keeping the phone still during the test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Analysis data missing for one subject.'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 14.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Partly', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 14. In addition to the basic instructions, did the study subject need additional support performing tests with Previct Drugs?\n\nResponse options:\n\n* Yes\n* No\n* Partly', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 16.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Partly', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 16. Was the study subject able to perform the test after receiving additional support?\n\nResponse options:\n\n* Yes\n* No\n* Partly', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS, the 10 subjects answering yes to usability question 14 (secondary endpoint 8)'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 17.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': '1-2 times', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': '3-4 times', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'More than 4 times', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 17. How many efforts did it take the study subject to perform test with Previct Drugs?\n\nResponse options:\n\n* 1-2 times\n* 3-4 times\n* More than 4 times', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Usability Questionnaire - Question 18.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'classes': [{'categories': [{'title': 'Very likely', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Likely', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Neither likely nor unlikely', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Unlikely', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Very unlikely', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 18. How likely do you think it is that the study subject will be able to perform tests with Previct Drugs without assistance in a home environment?\n\nResponse options:\n\n* Very likely\n* Likely\n* Neither likely nor unlikely\n* Unlikely\n* Very unlikely', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).\n\nPrevict Drugs: Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.'}], 'classes': [{'title': 'Successful tries - Non-convergence (NC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Successful tries - Horizontal nystagmus (NY)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Successful tries - Tremor (TR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Successful tries - Pupillary light reflex (PLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Successful tries - Redness (RED)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 4 weeks post baseline', 'description': "The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using native pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the native pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types.", 'unitOfMeasure': 'Number of tries', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of tries', 'denomUnitsSelected': 'Number of tries', 'populationDescription': 'All tries documented for each of the measurements; pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED), for the FAS population.'}, {'type': 'SECONDARY', 'title': 'Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).\n\nPrevict Drugs: Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.'}], 'classes': [{'title': 'Successful tries - Non-convergence (NC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Successful tries - Horizontal nystagmus (NY)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Successful tries - Tremor (TR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Successful tries - Pupillary light reflex (PLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Successful tries - Redness (RED)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'Number of tries', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 4 weeks post baseline', 'description': "The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using refined pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the refined pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types.", 'unitOfMeasure': 'Number of tries', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of tries', 'denomUnitsSelected': 'Number of tries', 'populationDescription': 'All tries documented for each of the measurements; pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED), for the FAS population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).\n\nPrevict Drugs: Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '25 subjects signed the informed consent, out of which 24 were eligible and are included in the Full Analysis Set (FAS) population.', 'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Visit 2 (Follow-up Visit 1)', 'comment': 'Optional visit', 'achievements': [{'comment': 'Out of the 24 enrolled subjects, 11 (44 %) conducted the optional first follow-up visit (Visit 2).', 'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Visit 3 (Follow-up Visit 2)', 'comment': 'Optional visit', 'achievements': [{'comment': 'Out of the 24 enrolled subjects, 5 (20 %) conducted the optional second follow-up visit (Visit 3).', 'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects With Confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population, patients with substance use disorder (SUD).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.9', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Timeline follow-back for drugs and alcohol. Question 1.', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Once a month or less often', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '2-4 times per month', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '2-3 times per week', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '4 times per week or more often', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Question 1. How often do you use drugs other than alcohol?\n\n* Never\n* Once a month or less often\n* 2-4 times per month\n* 2-3 times per week\n* 4 times per week or more often', 'unitOfMeasure': 'Participants'}, {'title': 'Timeline follow-back for drugs and alcohol. Question 2.', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Once a month or less often', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '2-4 times per month', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '2-3 times per week', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '4 times per week or more often', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Question 2. Do you use more than one drug on one occasion?\n\n* Never\n* Once a month or less often\n* 2-4 times per month\n* 2-3 times per week\n* 4 times per week or more often', 'unitOfMeasure': 'Participants'}, {'title': 'Timeline follow-back for drugs and alcohol. Question 3.', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '1-2 times', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '3-4 times', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '5-6 times', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '7 or more', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Question 3. How many times do you take drugs during a typical day when you use drugs?\n\n* 0\n* 1-2 times\n* 3-4 times\n* 5-6 times\n* 7 or more', 'unitOfMeasure': 'Participants'}, {'title': 'Timeline follow-back for drugs and alcohol. Question 4.', 'classes': [{'title': 'Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'BZ/Sleeping pills than alcohol?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Hashish, cannabis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Amphetamine, cocaine, ectasy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Morphone, heroine, buprenorphine, fentanyl, codeine, tramadol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Question 4. What have you consumed in the last 24 hours?\n\n* Alcohol\n* BZ/Sleeping pills than alcohol?\n* Hashish, cannabis\n* Amphetamine, cocaine, ectasy\n* Morphine, heroine, buprenorphine, fentanyl, codeine, tramadol\n* Other\n\nAll applicable were to be checked.', 'unitOfMeasure': 'Participants consuming the listed drug'}, {'title': 'Timeline follow-back for drugs and alcohol. Question 5.', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not affected', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Little affected', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Affected', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Very affected', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Question 5. How affected do you feel?\n\n* Not affected\n* Little affected\n* Affected\n* Very affected', 'unitOfMeasure': 'Participants'}, {'title': 'Timeline follow-back for drugs and alcohol. Question 6.', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'More than usual', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'As much as usual', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Less than usual', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Question 6. What has the intake looked like during the last 24 hours compared to how it usually is?\n\n* More than usual\n* As much as usual\n* Less than usual', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All eligible subjects = Full Analysis Set (FAS)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-05', 'size': 976068, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-28T08:38', 'hasProtocol': True}, {'date': '2023-08-15', 'size': 379688, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-28T08:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The investigation aims to enroll up to 30 SUD subjects. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined. It is based on available subjects from the clinic.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2023-02-10', 'resultsFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-05', 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability Questionnaire - Question 1.', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 1. Please evaluate the study subject's ability to use the mobile phone?\n\nResponse options:\n\n* Good\n* Manageable\n* Less good"}, {'measure': 'Usability Questionnaire - Question 2', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 2. How did you perceive the study subject's ability to follow the instructions given by Previct Drugs?\n\nResponse options:\n\n* Very good\n* Good\n* Either good or bad\n* Difficult\n* Very difficult"}, {'measure': 'Usability Questionnaire - Question 4', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 4. How did the study subject experience to put him/herself in the right position to be able to start a test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult'}, {'measure': 'Usability Questionnaire - Question 6', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 6. How would you evaluate the study subject's ability to perform a Cross-eyes test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult"}, {'measure': 'Usability Questionnaire - Question 8', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 8. How would you evaluate the study subject's ability to perform a Nystagmus test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult"}, {'measure': 'Usability Questionnaire - Question 10', 'timeFrame': 'Day 0 (Visit 1)', 'description': "Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 10. How would you evaluate the study subject's ability to perform a Contraction Test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult"}, {'measure': 'Usability Questionnaire - Question 12.', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 12. How did the study subject experience keeping the phone still during the test?\n\nResponse options:\n\n* Very easy\n* Easy\n* Either easy or difficult\n* Difficult\n* Very difficult'}, {'measure': 'Usability Questionnaire - Question 14.', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 14. In addition to the basic instructions, did the study subject need additional support performing tests with Previct Drugs?\n\nResponse options:\n\n* Yes\n* No\n* Partly'}, {'measure': 'Usability Questionnaire - Question 16.', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 16. Was the study subject able to perform the test after receiving additional support?\n\nResponse options:\n\n* Yes\n* No\n* Partly'}, {'measure': 'Usability Questionnaire - Question 17.', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 17. How many efforts did it take the study subject to perform test with Previct Drugs?\n\nResponse options:\n\n* 1-2 times\n* 3-4 times\n* More than 4 times'}, {'measure': 'Usability Questionnaire - Question 18.', 'timeFrame': 'Day 0 (Visit 1)', 'description': 'Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.\n\nQuestion 18. How likely do you think it is that the study subject will be able to perform tests with Previct Drugs without assistance in a home environment?\n\nResponse options:\n\n* Very likely\n* Likely\n* Neither likely nor unlikely\n* Unlikely\n* Very unlikely'}], 'secondaryOutcomes': [{'measure': 'Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder.', 'timeFrame': 'Up to 4 weeks post baseline', 'description': "The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using native pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the native pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types."}, {'measure': 'Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder.', 'timeFrame': 'Up to 4 weeks post baseline', 'description': "The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using refined pupillograms, i.e. proportion of successful tries. For each of the measurements pupillary light reflex (PLR), non-convergence (NC), horizontal nystagmus (NY), tremor (TR), and redness (RED) the measurements quality control will approve the measurement or not using the refined pupillogram. The proportion of approved measurements over all measurements will be calculated for each of the tests (PLR, NC, NY, TR, RED). The results includes all tries performed, including tries in two ambient light conditions. In case one test is not approved by the application's quality control, the application will instruct the subject to re-do the test. The number tests are thus more than the number of subjects included in the study, and can differ between the different test types."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Abuse']}, 'descriptionModule': {'briefSummary': 'This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.', 'detailedDescription': 'This second early feasibility study will give valuable information on the usability of Previct Drugs once being used in the intended population, i.e, patients with confirmed Substance Use Disorder (SUD). It will also give valuable information on the feasibility of Previct drugs function to measure pupils and eye movements in this population including evaluating the safety when using the device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Male and female\n* A recurrent visitor at Sprututbytesprogrammet in Uppsala defined as visited the clinic within the last three (3) months\n* SUD in accordanve with DSM-5 criteria according to investigator/designee judgement\n* Age 18 and above\n* Negative urine pregnancy test for all fertile women\n* Been informed of the nature, the scope, and the relevance of the clinical investigation\n* Voluntarily agreed on participation and has duly singed the Informed Consent Form\n\nExclusion Criteria:\n\n* Participating in another clinical investigation which may affect the study outcome according to clinical judgement\n* Pregnancy or lactating\n* Blind\n* Deaf\n* Any ECG dangerous arrythmia according to the investigator or designee judgement\n* Any disease or condition that may influence pupillary reflexes based on clinical judgement\n* Undergone eye surgery that may influence pupillary reflexes based on clinical judgement\n* Not able to read or understand the local language\n* Any planned travel or treatment which will make it impossible to participate according to the investigator or designee\n* Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate\n* That according to the Declaration of Helsinki is deemed unsuitable for study enrolment'}, 'identificationModule': {'nctId': 'NCT05737550', 'briefTitle': 'An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kontigo Care AB'}, 'officialTitle': 'A Second Explorative Pilot Study Evaluating Usability and Functionality of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With Confirmed Substance Use Disorder (SUD)', 'orgStudyIdInfo': {'id': 'KCClin02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with confirmed SUD', 'description': 'Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).', 'interventionNames': ['Device: Previct Drugs']}], 'interventions': [{'name': 'Previct Drugs', 'type': 'DEVICE', 'description': 'Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.', 'armGroupLabels': ['Subjects with confirmed SUD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75323', 'city': 'Uppsala', 'state': 'Uppland', 'country': 'Sweden', 'facility': 'Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Markku Hämäläinen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kontigo Care AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kontigo Care AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}