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

Age-Gate Validation Functionality Testing of the IKE Application

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 Overview

• Status: Completed
• Conditions: Vaping; Underage
• Intervention / Treatment: Other: 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.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • Alder Weiner, MARC Research facility partner
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Focus Center, MARC Research facility partner
  • New York
    • New York, New York, United States, 10036
      • L&E Research, MARC Research facility partner
  • Texas
    • Houston, Texas, United States, 77477
      • Creative Consumer Research, MARC Research facility partner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

General population

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Age 18-20, non user	Other: IKE System; Age-gate the access and activation of a device to authorized users of legal age; Other Names: IKE Application; IKE Bluetooth; IKE BLE
Age 21-24, Smoker, Vape user or Both	Other: IKE System; Age-gate the access and activation of a device to authorized users of legal age; Other Names: IKE Application; IKE Bluetooth; IKE BLE
Age 22-44, Smoker, Vape user or Both	Other: IKE System; Age-gate the access and activation of a device to authorized users of legal age; Other Names: IKE Application; IKE Bluetooth; IKE BLE
Age 45-64, Smoker, Vape user or Both	Other: IKE System; Age-gate the access and activation of a device to authorized users of legal age; Other Names: IKE Application; IKE Bluetooth; IKE BLE
Age 65 or older, Smoker, Vape user or Both	Other: IKE System; Age-gate the access and activation of a device to authorized users of legal age; Other Names: IKE Application; IKE Bluetooth; IKE BLE
Age 65 or older, Non-user	Other: IKE System; Age-gate the access and activation of a device to authorized users of legal age; Other Names: IKE Application; IKE Bluetooth; IKE BLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Day 1
Accurately identifies age, race/ethnicity, and gender	Error rate	Day 1

Collaborators and Investigators

• Sponsor: IKE Tech

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Access; e-cigarette; Youth; validation; e-cigarettes; software; ENDs; age-gate; age-verify; Bluetooth; BLE; IKE; Ispire
• Other Study ID Numbers: Pro00083344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No