An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD

Not Applicable

Completed

Conditions: Drug Abuse

Interventions: Device: Previct Drugs

Registration Number: NCT05737550

Lead Sponsor: Kontigo Care AB

Brief Summary: This will be a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data for Previct Drugs.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Signed Informed Consent Form
Male and female
A recurrent visitor at Sprututbytesprogrammet in Uppsala defined as visited the clinic within the last three (3) months
SUD in accordanve with DSM-5 criteria according to investigator/designee judgement
Age 18 and above
Negative urine pregnancy test for all fertile women
Been informed of the nature, the scope, and the relevance of the clinical investigation
Voluntarily agreed on participation and has duly singed the Informed Consent Form

Exclusion Criteria

Participating in another clinical investigation which may affect the study outcome according to clinical judgement
Pregnancy or lactating
Blind
Deaf
Any ECG dangerous arrythmia according to the investigator or designee judgement
Any disease or condition that may influence pupillary reflexes based on clinical judgement
Undergone eye surgery that may influence pupillary reflexes based on clinical judgement
Not able to read or understand the local language
Any planned travel or treatment which will make it impossible to participate according to the investigator or designee
Any other condition that as judged by the investigator may make the follow-up or investigation inappropriate
That according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with confirmed SUD	Previct Drugs	Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).

Primary Outcome Measures

Name	Time	Method
Usability Questionnaire - Question 1.	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 1. Please evaluate the study subject's ability to use the mobile phone? Response options: * Good * Manageable * Less good
Usability Questionnaire - Question 2	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 2. How did you perceive the study subject's ability to follow the instructions given by Previct Drugs? Response options: * Very good * Good * Either good or bad * Difficult * Very difficult
Usability Questionnaire - Question 4	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 4. How did the study subject experience to put him/herself in the right position to be able to start a test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Usability Questionnaire - Question 6	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 6. How would you evaluate the study subject's ability to perform a Cross-eyes test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Usability Questionnaire - Question 8	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 8. How would you evaluate the study subject's ability to perform a Nystagmus test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Usability Questionnaire - Question 10	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 10. How would you evaluate the study subject's ability to perform a Contraction Test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Usability Questionnaire - Question 12.	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 12. How did the study subject experience keeping the phone still during the test? Response options: * Very easy * Easy * Either easy or difficult * Difficult * Very difficult
Usability Questionnaire - Question 14.	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 14. In addition to the basic instructions, did the study subject need additional support performing tests with Previct Drugs? Response options: * Yes * No * Partly
Usability Questionnaire - Question 16.	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 16. Was the study subject able to perform the test after receiving additional support? Response options: * Yes * No * Partly
Usability Questionnaire - Question 17.	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 17. How many efforts did it take the study subject to perform test with Previct Drugs? Response options: * 1-2 times * 3-4 times * More than 4 times
Usability Questionnaire - Question 18.	Day 0 (Visit 1)	Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions. Question 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? Response options: * Very likely * Likely * Neither likely nor unlikely * Unlikely * Very unlikely

Secondary Outcome Measures

Name	Time	Method
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms for Patients With Substance Use Disorder.	Up to 4 weeks post baseline	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.
Evaluate if Self-administered Pupillometry Using a Mobile Phone Application, After Refinement, Can be Used to Collect Pupillograms From Patients With Substance Use Disorder.	Up to 4 weeks post baseline	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.