Back to resultsAn Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD
Primary Purpose
Drug Abuse
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Previct Drugs
Sponsored by
About this trial
This is an interventional other trial for Drug Abuse
Eligibility Criteria
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
Sites / Locations
- Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with confirmed SUD
Arm Description
Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).
Outcomes
Primary Outcome Measures
Evaluate if the user-interface of the mobile phone application Previct Drugs is suitable to be used by patients with substance use disorder.
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.
Secondary Outcome Measures
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.
Evaluate if self-administered pupillometry using a mobile phone application, after refining the method for establishing pupillograms and key feature extraction algorithms, 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 and and key feature extraction algorithms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05737550
Brief Title
An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
June 28, 2023 (Actual)
Study Completion Date
June 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kontigo Care AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with confirmed SUD
Arm Type
Experimental
Arm Description
Evaluation of the usability of Previct Drugs when used in the intended population (patients with SUD).
Intervention Type
Device
Intervention Name(s)
Previct Drugs
Intervention 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.
Primary Outcome Measure Information:
Title
Evaluate if the user-interface of the mobile phone application Previct Drugs is suitable to be used by patients with substance use disorder.
Description
Observation of a study subject during a test with Previct Drugs through answering a usability questionnaire consisting of 18 usability questions.
Time Frame
Up to 4 weeks post baseline
Secondary Outcome Measure Information:
Title
Evaluate if self-administered pupillometry using a mobile phone application can be used to collect pupillograms for patients with substance use disorder.
Description
The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using native pupillograms.
Time Frame
Up to 4 weeks post baseline
Title
Evaluate if self-administered pupillometry using a mobile phone application, after refining the method for establishing pupillograms and key feature extraction algorithms, can be used to collect pupillograms from patients with substance use disorder.
Description
The fraction of collected pupillometry data from the mobile phone application, which can be transformed into pre-defined key features using refined pupillograms and and key feature extraction algorithms.
Time Frame
Up to 4 weeks post baseline
Other Pre-specified Outcome Measures:
Title
Evaluate safety of using the mobile phone application Previct Drugs
Description
The incidence and severity of adverse events associated with Previct Drugs
Time Frame
Through study completion, an average of 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markku Hämäläinen, PhD
Organizational Affiliation
Kontigo Care AB
Official's Role
Study Chair
Facility Information:
Facility Name
Mottagning för särskild vård, sprutbytet, Husläkarmottagning för hemlösa
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75323
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
An Explorative Pilot Study of a New Mobile Phone Application Measuring Eye Parameters of Eyes in Patients With SUD
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