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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.
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:
Upon successful Bluetooth connection to the device via the IKE application:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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, Smoker, Vape user or Both |
| ||
| Age 65 or older, Non-user |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IKE System | Other | Age-gate the access and activation of a device to authorized users of legal age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accurately age-verify users using a government ID and live photo | Error rate | Day 1 |
| Prevents users under 21 year of age from enabling IKE application | Pass or Fail | Day 1 |
| Allows users age 21 and older to enable IKE application | Pass or Fail | Day 1 |
| IKE application connects to and activates a device for users over 21 years of age | Pass or Fail | Day 1 |
| Users are able to download the IKE application | Task completion Error rate | Day 1 |
| Device disconnects and powers off within 15 minutes of idling (no use) | Pass or Fail | Day 1 |
| Device is disconnected and powered off after losing Bluetooth signal | Pass or Fail | Day 1 |
| User is able to reactivate the device after being disconnected and powered off | Task completion | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| User download the IKE application on personal smartphone | Error rate | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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General population
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alder Weiner, MARC Research facility partner | Los Angeles | California | 90024 | United States | ||
| Focus Center, MARC Research facility partner |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 7, 2025 | |
| Reset | May 27, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 7, 2025 | May 27, 2025 |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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|
| Day 1 |
| Accurately identifies age, race/ethnicity, and gender | Error rate | Day 1 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| L&E Research, MARC Research facility partner | New York | New York | 10036 | United States |
| Creative Consumer Research, MARC Research facility partner | Houston | Texas | 77477 | United States |