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

NCT ID: NCT06952569

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-18

Study Completion Date

2025-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vaping Underage

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Age 18-20, non user

IKE System

Intervention Type OTHER

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

Age 21-24, Smoker, Vape user or Both

IKE System

Intervention Type OTHER

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

Age 22-44, Smoker, Vape user or Both

IKE System

Intervention Type OTHER

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

Age 45-64, Smoker, Vape user or Both

IKE System

Intervention Type OTHER

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

Age 65 or older, Smoker, Vape user or Both

IKE System

Intervention Type OTHER

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

Age 65 or older, Non-user

IKE System

Intervention Type OTHER

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

Interventions

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IKE System

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

Intervention Type OTHER

Other Intervention Names

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IKE Application IKE Bluetooth IKE BLE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IKE Tech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alder Weiner, MARC Research facility partner

Los Angeles, California, United States

Site Status

Focus Center, MARC Research facility partner

Chicago, Illinois, United States

Site Status

L&E Research, MARC Research facility partner

New York, New York, United States

Site Status

Creative Consumer Research, MARC Research facility partner

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00083344

Identifier Type: -

Identifier Source: org_study_id

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