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

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)

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

Study Overview

• Status: Completed
• Conditions: Drug Abuse
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppland
    • Uppsala, Uppland, Sweden, 75323
      • Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Subjects with confirmed SUD; Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).

Device: Previct 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability Questionnaire - Question 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	Day 0 (Visit 1)
Usability Questionnaire - Question 2	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	Day 0 (Visit 1)
Usability Questionnaire - Question 4	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	Day 0 (Visit 1)
Usability Questionnaire - Question 6	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	Day 0 (Visit 1)
Usability Questionnaire - Question 8	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	Day 0 (Visit 1)
Usability Questionnaire - Question 10	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	Day 0 (Visit 1)
Usability Questionnaire - Question 12.	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	Day 0 (Visit 1)
Usability Questionnaire - Question 14.	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	Day 0 (Visit 1)
Usability Questionnaire - Question 16.	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	Day 0 (Visit 1)
Usability Questionnaire - Question 17.	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	Day 0 (Visit 1)
Usability Questionnaire - Question 18.	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	Day 0 (Visit 1)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate safety of using the mobile phone application Previct Drugs	The incidence and severity of adverse events associated with Previct Drugs	Through study completion, an average of 4 weeks

Collaborators and Investigators

• Sponsor: Kontigo Care AB
• Investigators: Study Chair: Markku Hämäläinen, PhD, Kontigo Care AB

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: KCClin02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No