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Completed

NCT Number: NCT06952569

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alder Weiner, MARC Research facility partner, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

IKE System

Other

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

Other names: IKE Application, IKE Bluetooth, IKE BLE

Primary outcomes

  1. Accurately age-verify users using a government ID and live photo

    Time frame: Day 1

    Error rate

  2. Prevents users under 21 year of age from enabling IKE application

    Time frame: Day 1

    Pass or Fail

  3. Allows users age 21 and older to enable IKE application

    Time frame: Day 1

    Pass or Fail

  4. IKE application connects to and activates a device for users over 21 years of age

    Time frame: Day 1

    Pass or Fail

  5. Users are able to download the IKE application

    Time frame: Day 1

    Task completion Error rate

  6. Device disconnects and powers off within 15 minutes of idling (no use)

    Time frame: Day 1

    Pass or Fail

  7. Device is disconnected and powered off after losing Bluetooth signal

    Time frame: Day 1

    Pass or Fail

  8. User is able to reactivate the device after being disconnected and powered off

    Time frame: Day 1

    Task completion

Secondary outcomes

  1. User download the IKE application on personal smartphone

    Time frame: Day 1

    Error rate

  2. Perceived Ease of IKE Application Account Setup

    Time frame: Day 1

    Extremely Easy (1), Very Easy (2), Somewhat Easy (3), Not very easy (4), Not at all easy (5)

  3. Accurately identifies age, race/ethnicity, and gender

    Time frame: Day 1

    Error rate

Sponsors and collaborators

Lead sponsor

IKE Tech

Industry

Registry information

Official study title

Age-Gate Validation Functionality Testing of the IKE Application

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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