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Human Factors Validation and Usability Testing of the IKE Age-Gating System

Age-Gate Validation Functionality Testing of the IKE Application

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06952569
Enrollment
102
Registered
2025-05-01
Start date
2025-02-18
Completion date
2025-03-30
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Underage, Vaping

Keywords

Youth, ENDs, e-cigarette, e-cigarettes, age-gate, age-verify, Bluetooth, BLE, validation, software, IKE, Ispire, Access

Brief 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.

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.

Interventions

OTHERIKE System

Age-gate the access and activation of a device to authorized users of legal age

Sponsors

IKE Tech
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Currently live in proximity to one of the four central location sites 2. Ages 18 and older 3. Have a valid driver's license or US government-issued identification with picture 4. Currently use a smartphone with an iOS (Apple) or Android operating system 5. Indicate somewhat (3), very (4), or extremely (5) comfortable using smartphone applications on intake questionnaire 6. Able and willing to comply with all study requirements 7. Review and sign informed consent

Exclusion criteria

1. Under 18 years of age 2. Among 21-64 years of age, do not currently use cigarettes or vape products 3. Do not own or use a smartphone with an iOS (Apple) or Android operating system 4. Unable to download any smartphone application 5. 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

Design outcomes

Primary

MeasureTime frameDescription
Prevents users under 21 year of age from enabling IKE applicationDay 1Pass or Fail
User is able to reactivate the device after being disconnected and powered offDay 1Task completion
Accurately age-verify users using a government ID and live photoDay 1Error rate
Allows users age 21 and older to enable IKE applicationDay 1Pass or Fail
IKE application connects to and activates a device for users over 21 years of ageDay 1Pass or Fail
Users are able to download the IKE applicationDay 1Task completion Error rate
Device disconnects and powers off within 15 minutes of idling (no use)Day 1Pass or Fail
Device is disconnected and powered off after losing Bluetooth signalDay 1Pass or Fail

Secondary

MeasureTime frameDescription
User download the IKE application on personal smartphoneDay 1Error rate
Perceived Ease of IKE Application Account SetupDay 1Extremely Easy (1), Very Easy (2), Somewhat Easy (3), Not very easy (4), Not at all easy (5)
Accurately identifies age, race/ethnicity, and genderDay 1Error rate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026