Clinical trial NCT06952569: Human Factors Validation and Usability Testing of the IKE Age-Gating System
Official title: Age-Gate Validation Functionality Testing of the IKE Application
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaping
Underage
Keywords: Youth
ENDs
e-cigarette
e-cigarettes
age-gate
age-verify
Bluetooth
BLE
validation
software
IKE
Ispire
Access
Lead sponsor: Ispire Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: General population

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accurately age-verify users using a government ID and live photo
timeFrame: Day 1
measure: Prevents users under 21 year of age from enabling IKE application
timeFrame: Day 1
measure: Allows users age 21 and older to enable IKE application
timeFrame: Day 1
measure: IKE application connects to and activates a device for users over 21 years of age
timeFrame: Day 1
measure: Users are able to download the IKE application
timeFrame: Day 1
measure: Device disconnects and powers off within 15 minutes of idling (no use)
timeFrame: Day 1
measure: Device is disconnected and powered off after losing Bluetooth signal
timeFrame: Day 1
measure: User is able to reactivate the device after being disconnected and powered off
timeFrame: Day 1
Secondary outcomes:
measure: User download the IKE application on personal smartphone
timeFrame: Day 1
measure: Perceived Ease of IKE Application Account Setup
timeFrame: Day 1
measure: Accurately identifies age, race/ethnicity, and gender
timeFrame: Day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Alder Weiner, MARC Research facility partner
state: California
city: Chicago
country: United States
facility: Focus Center, MARC Research facility partner
state: Illinois
city: New York
country: United States
facility: L&E Research, MARC Research facility partner
state: New York
city: Houston
country: United States
facility: Creative Consumer Research, MARC Research facility partner
state: Texas
Study officials:
References: