Substance AbuseNCT02794038
Accuracy & Usability Study for Soberlink Cellular Device
A study testing Soberlink Cellular Device and BACtrack S80 Pro in people with Substance Abuse, run by Soberlink Healthcare LLC.
Trial summary
This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Soberlink Cellular Device and BACtrack S80 Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject willing to sign an informed consent
- Male or female subject between the ages of 21-99 years old
- Untrained subject in the use of an Alcohol Breathalyzer
- Subject willing to consume two alcoholic drinks
- Subjects willing to use two Alcohol Breathalyzers
- Subject willing to complete a Questionnaire
Who cannot join
- Subject with previous Alcohol Breathalyzer experience
- Subject currently in substance use rehabilitation or post rehabilitation, or unauthorized to consume alcohol for any other reason
- Subject with lung disease, or is physically unable to provide a deep lung exhalation for 4 seconds
- Subject unwilling to drink two alcoholic drinks
- Subject unwilling to complete a questionnaire
- Subject that is non-English speaking
- Subject that is a child, adolescent, or cognitively impaired.
- Subject that is a pregnant and/or breastfeeding woman
About this study
This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.
Read the detailed description
The purpose of this accuracy and usability study is to validate the performance of Soberlink Cellular Device in the hands of the intended (lay) users - untrained study participants who have consumed alcohol and use the Soberlink Cellular Device to measure their blood alcohol content (BAC) in comparison to a predicate device.
The purpose of this document is to define how the human factors environment impacts the actual user interface design as well as how usability engineering evaluates user interface via usability objectives and usability tests. This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6 (collateral standard for usability engineering of medical electrical equipment), and IEC 62366 (application of usability engineering to medical devices).
- Conditions
- Substance Abuse
- Being tested
- Soberlink Cellular Device, BACtrack S80 Pro
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soberlink Cellular DeviceDevice
BAC breath analyzer
BACtrack S80 ProDevice
BAC breath analyzer
| Study group | Role | What they receive |
|---|---|---|
| Soberlink Cellular Device | Active comparator | BAC reading with Soberlink Cellular Device Receives: Device: BACtrack S80 Pro |
| BACtrack S80 Pro | Active comparator | BAC reading with BACtrack S80 Pro Receives: Device: Soberlink Cellular Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression.
Performance validation will occur by evaluating the accuracy of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and use the device to measure their blood alcohol content (BAC). 40 adults will be recruited who have recently consumed alcohol. The only assistance to be provided is the labeling. No additional coaching, either written or verbal, will be provided to study participants. Participants should obtain a BAC reading with the Soberlink Cellular device, and a second BAC reading with a comparator device. The second measurement will be taken within 5 minutes of the first. A linear regression line for the comparison between results of the Soberlink Cellular device and a comparator will be made.
Measured: Day 1
Secondary outcomes (1)
Validate the usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by Questionnaire.
Performance validation will occur by evaluating the usability of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and used the device to measure their blood alcohol content (BAC). 40 adults who have recently consumed alcohol will be asked to evaluate the Soberlink Cellular device. The only assistance provided is the labeling. No additional coaching, either written or verbal, will be provided to study participants. Participants should obtain a BAC reading with the Soberlink Cellular device, and a second BAC reading with a comparator device. The second measurement should be taken within 5 minutes of the first. Following the second measurement a questionnaire will be administered to study participants to evaluate the ease of use of the Soberlink Cellular device.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soberlink Healthcare LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shannon Hanrahan, PhD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794038
- Sponsor's protocol ID
- ACUSPROT 2016-001
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Participant will be aware of their own BAC result as the result is displayed on the LED screen of the device
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy & Usability Study for Soberlink Cellular Device
- ClinicalTrials.gov ID
- NCT02794038
- Acronym / sponsor ID
- ACUSPROT 2016-001
- Conditions
- Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Soberlink Healthcare LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.
Detailed description
The purpose of this accuracy and usability study is to validate the performance of Soberlink Cellular Device in the hands of the intended (lay) users - untrained study participants who have consumed alcohol and use the Soberlink Cellular Device to measure their blood alcohol content (BAC) in comparison to a predicate device.
The purpose of this document is to define how the human factors environment impacts the actual user interface design as well as how usability engineering evaluates user interface via usability objectives and usability tests. This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6 (collateral standard for usability engineering of medical electrical equipment), and IEC 62366 (application of usability engineering to medical devices).
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soberlink Cellular Device | Active comparator | Device: BACtrack S80 ProBAC reading with Soberlink Cellular Device |
| BACtrack S80 Pro | Active comparator | Device: Soberlink Cellular DeviceBAC reading with BACtrack S80 Pro |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject willing to sign an informed consent
- Male or female subject between the ages of 21-99 years old
- Untrained subject in the use of an Alcohol Breathalyzer
- Subject willing to consume two alcoholic drinks
- Subjects willing to use two Alcohol Breathalyzers
Key exclusion criteria (8 listed)
- Subject with previous Alcohol Breathalyzer experience
- Subject currently in substance use rehabilitation or post rehabilitation, or unauthorized to consume alcohol for any other reason
- Subject with lung disease, or is physically unable to provide a deep lung exhalation for 4 seconds
- Subject unwilling to drink two alcoholic drinks
- Subject unwilling to complete a questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soberlink Cellular DeviceBAC breath analyzer | Device | BACtrack S80 Pro |
| BACtrack S80 ProBAC breath analyzer | Device | Soberlink Cellular Device |
Primary outcome
Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression.
Time frame: Day 1
Performance validation will occur by evaluating the accuracy of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and use the device to measure their blood alcohol content (BAC). 40 adults will be recruited who have recently consumed alcohol. The only assistance to be provided is the labeling. No additional coaching, either written or verbal, will be provided to study participants. Participants should obtain a BAC reading with the Soberlink Cellular device, and a second BAC reading with a comparator device. The second measurement will be taken within 5 minutes of the first. A linear regression line for the comparison between results of the Soberlink Cellular device and a comparator will be made.
1 secondary outcome
Validate the usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by Questionnaire.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Individual participant dataSharing planned: Yes. Participant will be aware of their own BAC result as the result is displayed on the LED screen of the device
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Hanrahan, PhD principal investigator
Private Practice
Questions about this trial
What is this clinical trial studying?
A study testing Soberlink Cellular Device and BACtrack S80 Pro in people with Substance Abuse, run by Soberlink Healthcare LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.