VapingNCT06952569
Human Factors Validation and Usability Testing of the IKE Age-Gating System
An observational study of Vaping and Underage, run by IKE Tech at 4 sites in United States.
Trial summary
A multi-center human factors validation study to demonstrate the function of the IKE Bluetooth system on a chip (SoC) and mobile applications ability to age-gate a device, accurately identify an individuals age, race/ethnicity, and gender, and asses the usability of the IKE System. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- IKE System
- How many people
- 102 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Feb 2025to 30 Mar 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population
Who may be able to join
- Currently live in proximity to one of the four central location sites
- Ages 18 and older
- Have a valid driver's license or US government-issued identification with picture
- Currently use a smartphone with an iOS (Apple) or Android operating system
- Indicate somewhat (3), very (4), or extremely (5) comfortable using smartphone applications on intake questionnaire
- Able and willing to comply with all study requirements
- Review and sign informed consent
Who cannot join
- Under 18 years of age
- Among 21-64 years of age, do not currently use cigarettes or vape products
- Do not own or use a smartphone with an iOS (Apple) or Android operating system
- Unable to download any smartphone application
- Employees of or household member employed in advertising/marketing, market research, healthcare, legal field, news and media, or local, state or US Federal government to minimize bias and to protect any proprietary product information that will be disclosed in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Focus Center, MARC Research facility partner
Chicago, Illinois, 60611
Creative Consumer Research, MARC Research facility partner
Houston, Texas, 77477
Alder Weiner, MARC Research facility partner
Los Angeles, California, 90024
L&E Research, MARC Research facility partner
New York, New York, 10036
About this study
Official title: Age-Gate Validation Functionality Testing of the IKE Application
A multi-center human factors validation study to demonstrate the function of the IKE Bluetooth system on a chip (SoC) and mobile applications ability to age-gate a device, accurately identify an individuals age, race/ethnicity, and gender, and asses the usability of the IKE System.
Read the detailed description
Study Objectives:
IKE developed a smartphone application which identifies and age-verifies users and works in conjunction with a Bluetooth low energy (BLE) chip to restrict connecting to and activating a device by a users age. The intention is to use this in ENDs devices, and therefore the age limit was set to 21 years. This feature is generally referred to as "age-gating."
The purpose of the study is to:
- Generally establish the ability of individuals to successfully download and use the IKE application
- Confirm the identification and age-verification application works effectively to prevent those under 21 from enabling the IKE application
- Confirm the identification and age-verification application works effectively to allow those 21 years of age or older to enable the IKE application
- Establish that only individual over 21 years of age is able to connect a device to the IKE application via Bluetooth
Upon successful Bluetooth connection to the device via the IKE application:
- Confirm the Maximum Idle Time function works by disconnecting the device and powering the device off within a maximum of 15 minutes
- Confirm the Out of Bluetooth Range function works specific to connection of the Vape device to the smartphone (Vape device will be placed in Faraday bag to force disconnect from smartphone) and the user can re-activate the device
- Confirm users are able to reactivate the same device after either Maximum Idle Time disconnect or Out of Bluetooth Range disconnect
Establish the ability of an identity and age-verified individual to log-in to the application on a secondary device (in this case a tablet) and effectively connect the device using Bluetooth while simultaneously forcing disconnection of the previously connected device
Further, the research is designed to have participants use the smartphone application in as natural as possible setting without direct instruction to simulate a real-world use setting.
- Being tested
- IKE System
- Keywords
- Youth, ENDs, e-cigarette, e-cigarettes, age-gate, age-verify, Bluetooth, BLE, validation, software, IKE, Ispire, Access
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IKE SystemOther
Also called IKE Application, IKE Bluetooth, IKE BLE
Age-gate the access and activation of a device to authorized users of legal age
| Study group | Role | What they receive |
|---|---|---|
| Age 18-20, non user | Not described Receives: Other: IKE System | |
| Age 21-24, Smoker, Vape user or Both | Not described Receives: Other: IKE System | |
| Age 22-44, Smoker, Vape user or Both | Not described Receives: Other: IKE System | |
| Age 45-64, Smoker, Vape user or Both | Not described Receives: Other: IKE System | |
| Age 65 or older, Smoker, Vape user or Both | Not described Receives: Other: IKE System | |
| Age 65 or older, Non-user | Not described Receives: Other: IKE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurately age-verify users using a government ID and live photo
Error rate
Measured: Day 1
Prevents users under 21 year of age from enabling IKE application
Pass or Fail
Measured: Day 1
Allows users age 21 and older to enable IKE application
Pass or Fail
Measured: Day 1
IKE application connects to and activates a device for users over 21 years of age
Pass or Fail
Measured: Day 1
Users are able to download the IKE application
Task completion Error rate
Measured: Day 1
Device disconnects and powers off within 15 minutes of idling (no use)
Pass or Fail
Measured: Day 1
Device is disconnected and powered off after losing Bluetooth signal
Pass or Fail
Measured: Day 1
User is able to reactivate the device after being disconnected and powered off
Task completion
Measured: Day 1
Secondary outcomes (3)
User download the IKE application on personal smartphone
Error rate
Measured: Day 1
Perceived Ease of IKE Application Account Setup
Extremely Easy (1), Very Easy (2), Somewhat Easy (3), Not very easy (4), Not at all easy (5)
Measured: Day 1
Accurately identifies age, race/ethnicity, and gender
Error rate
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 posted1 May 2025
- Study start18 Feb 2025
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- IKE Tech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952569
- Sponsor's protocol ID
- Pro00083344
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Gate Validation Functionality Testing of the IKE Application
- ClinicalTrials.gov ID
- NCT06952569
- Acronym / sponsor ID
- Pro00083344
- Keywords
- Youth, ENDs, e-cigarette, e-cigarettes, age-gate, age-verify, Bluetooth, BLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- IKE TechIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 1 May 2025 (actual)
- 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.
A multi-center human factors validation study to demonstrate the function of the IKE Bluetooth system on a chip (SoC) and mobile applications ability to age-gate a device, accurately identify an individuals age, race/ethnicity, and gender, and asses the usability of the IKE System.
Detailed description
Study Objectives:
IKE developed a smartphone application which identifies and age-verifies users and works in conjunction with a Bluetooth low energy (BLE) chip to restrict connecting to and activating a device by a users age. The intention is to use this in ENDs devices, and therefore the age limit was set to 21 years. This feature is generally referred to as "age-gating."
The purpose of the study is to:
- Generally establish the ability of individuals to successfully download and use the IKE application
- Confirm the identification and age-verification application works effectively to prevent those under 21 from enabling the IKE application
- Confirm the identification and age-verification application works effectively to allow those 21 years of age or older to enable the IKE application
- Establish that only individual over 21 years of age is able to connect a device to the IKE application via Bluetooth
Upon successful Bluetooth connection to the device via the IKE application:
- Confirm the Maximum Idle Time function works by disconnecting the device and powering the device off within a maximum of 15 minutes
- Confirm the Out of Bluetooth Range function works specific to connection of the Vape device to the smartphone (Vape device will be placed in Faraday bag to force disconnect from smartphone) and the user can re-activate the device
- Confirm users are able to reactivate the same device after either Maximum Idle Time disconnect or Out of Bluetooth Range disconnect
Establish the ability of an identity and age-verified individual to log-in to the application on a secondary device (in this case a tablet) and effectively connect the device using Bluetooth while simultaneously forcing disconnection of the previously connected device
Further, the research is designed to have participants use the smartphone application in as natural as possible setting without direct instruction to simulate a real-world use setting.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Age 18-20, non user | – | Other: IKE System |
| Age 21-24, Smoker, Vape user or Both | – | Other: IKE System |
| Age 22-44, Smoker, Vape user or Both | – | Other: IKE System |
| Age 45-64, Smoker, Vape user or Both | – | Other: IKE System |
| Age 65 or older, Smoker, Vape user or Both | – | Other: IKE System |
| Age 65 or older, Non-user | – | Other: IKE System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (7 listed)
- Currently live in proximity to one of the four central location sites
- Ages 18 and older
- Have a valid driver's license or US government-issued identification with picture
- Currently use a smartphone with an iOS (Apple) or Android operating system
- Indicate somewhat (3), very (4), or extremely (5) comfortable using smartphone applications on intake questionnaire
Key exclusion criteria (5 listed)
- Under 18 years of age
- Among 21-64 years of age, do not currently use cigarettes or vape products
- Do not own or use a smartphone with an iOS (Apple) or Android operating system
- Unable to download any smartphone application
- Employees of or household member employed in advertising/marketing, market research, healthcare, legal field, news and media, or local, state or US Federal government to minimize bias and to protect any proprietary product information that will be disclosed in the study
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 |
|---|---|---|
| IKE SystemAlso: IKE Application, IKE Bluetooth, IKE BLEAge-gate the access and activation of a device to authorized users of legal age | Other | Age 18-20, non user, Age 21-24, Smoker, Vape user or Both, Age 22-44, Smoker, Vape user or Both, Age 45-64, Smoker, Vape user or Both, Age 65 or older, Non-user, Age 65 or older, Smoker, Vape user or Both |
Primary outcome
Accurately age-verify users using a government ID and live photo
Time frame: Day 1
Error rate
Prevents users under 21 year of age from enabling IKE application
Time frame: Day 1
Pass or Fail
Allows users age 21 and older to enable IKE application
Time frame: Day 1
Pass or Fail
IKE application connects to and activates a device for users over 21 years of age
Time frame: Day 1
Pass or Fail
Users are able to download the IKE application
Time frame: Day 1
Task completion Error rate
Device disconnects and powers off within 15 minutes of idling (no use)
Time frame: Day 1
Pass or Fail
Device is disconnected and powered off after losing Bluetooth signal
Time frame: Day 1
Pass or Fail
User is able to reactivate the device after being disconnected and powered off
Time frame: Day 1
Task completion
3 secondary outcomes
User download the IKE application on personal smartphone
Time frame: Day 1
Perceived Ease of IKE Application Account Setup
Time frame: Day 1
Accurately identifies age, race/ethnicity, and gender
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 1 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaping and Underage, run by IKE Tech at 4 sites in United States.
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 7 inclusion and 5 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 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Accurately age-verify users using a government ID and live photo (time frame: Day 1). The study lists 8 primary outcomes in all. 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 1 May 2025.