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

IKE Tech

Status: Completed

Conditions: Underage; Vaping

Treatments: Other: IKE System

Study type: Observational

Funder types: Industry

Identifiers

NCT06952569

Pro00083344

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

102 participants in 6 patient groups

Age 18-20, non user

Treatment:

Other: IKE System

Age 21-24, Smoker, Vape user or Both

Treatment:

Other: IKE System

Age 22-44, Smoker, Vape user or Both

Treatment:

Other: IKE System

Age 45-64, Smoker, Vape user or Both

Treatment:

Other: IKE System

Age 65 or older, Smoker, Vape user or Both

Treatment:

Other: IKE System

Age 65 or older, Non-user

Treatment:

Other: IKE System