A Pilot Study Comparing Performance of Blind Participants on 12 Tasks, With and Without the ARIA Device

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorARIA Research Pty Ltd

About this trial

Summary The environment in which we live, play and travel is primarily built by and for people with sight. Navigating the sighted world with blindness can be exhausting, as it involves disorientation, social isolation, increased risk, frustration and inefficiency. Accessing timely information about the environment is necessary to navigate an efficient path of travel and reduce the effort involved in living with blindness.

Numerous assistive technologies have been developed to improve access to information, and quality of life for people with blindness, however persistent technology limitations include affordability, unreliable internet connection, lag and limited battery life. Existing technologies can offer scene description or text-to-voice quite effectively when the user is standing still, but not quickly enough to gain benefit when on the move. Timely information is crucial at road crossings, where poor decisions can result in injury. Information lag or deficit also compounds travel fatigue due to time and energy wasted in searching, uncertainty and frustration.

Blind users are often brought in to test new technologies or devices in controlled, clinical conditions, when it is too late to influence design. There is little evidence of testing these technologies in lived environments to understand the functional benefits for the blind population, partly because there is a dearth of available methods and measures to embrace the complexity of functional research.

This study will test the safety, efficacy and usability of the ARIA Device in 12 varied research tasks undertaken by blind participants in clinical, social and outdoor lived environments, comparing ARIA performance with each participant's ordinary (non-ARIA) methods of undertaking the same tasks. The study uses an embedded mixed methods design with a qualitative priority, generating rich, precise data about what matters to participants and what they can do in diverse situations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals over the age of 18

Working English proficiency

No light perception, or light perception only (VROOM score <10/50).

Ambulant, with sufficient stamina to stand/walk for at least 30 minutes between breaks during a 3-4 hour research session.

Disqualifiers

Under 18 years, or adults unable to give informed consent (e.g., under guardianship).

Vision greater than light perception only (VROOM >10/50).

Physical limitations that compromise stamina needed to complete a four-hour research session.

Hearing aids; severe-profound hearing loss determined as insufficient hearing for unaided conversation

Trial design

Design model

Crossover

Treatments tested in this trial

  • ARIA Glasses ( Augmented Reality in Audio )

    Device

    ARIA stands for Augmented Reality in Audio. The ARIA Device consists of Augmented Reality glasses connected by cord to a dedicated mobile phone that has the ARIA app installed. The glasses include cameras, speakers and an inertial measurement unit. The phone app uses artificial intelligence to convert camera vision from the glasses into a soundscape that includes words and unique sounds identifying specific objects nearby, and an audio rendering of depth that estimates the user's distance from solid matter. This soundscape is delivered to the user via an amplifier that enables volume control and switch-off. The soundscape is designed to augment rather than replace natural hearing, increasing the user's perceptual access to details in the nearby environment.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: With ARIA GlassesActive comparator 1 intervention
Group B: Without ARIA GlassesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ARIA Device Safety

Absence of device-related adverse events (AEs) including safe temperature (no burns), safe skin contact (no irritation), safe pressure (no hot spots, bruising), and safe sound levels (no ringing in the ears). AE summaries will be restricted to treatment-emergent AEs (TEAEs) only, defined as AEs which commence, or worsen in severity, on or after the first use of the ARIA Device. AEs will be assessed according to their adverse event-device relationship (not related, unlikely, possible, probable, definitely related) and their severity (mild, moderate, severe).

Time frame
Safety and participant wellbeing is monitored throughout the 4 on-site research sessions, with TEAEs noted on data collection forms for evaluation by the PI, reported to Sponsor and Monitor immediately if severe (within 24 hours) or otherwise within 7day

Secondary outcomes

1

Secondary outcomes include efficacy endpoints, usability endpoints and exploratory endpoints.

Completion of 12 research tasks, with and without the ARIA Device, to assess efficacy of the ARIA Device.

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ARIA Research Pty Ltd

Lead sponsor

University of Sydney

Collaborator