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

NCT06477809 | Recruiting

• 1 other identifier: CIP-01-ARIA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blindness and Low Vision

Outcome Measures

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).

  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.

  Through study completion, an average of 1 year

Study Arms (2)

With ARIA Glasses

ACTIVE COMPARATOR

Each participant will act as their own control by performing the 12 research tasks with and without the ARIA Device, using their long cane as they choose in both conditions. The control arm will be the participant's ordinary/preferred practice undertaking each task, referred to as non-ARIA.

Device: ARIA Glasses ( Augmented Reality in Audio )

Without ARIA Glasses

ACTIVE COMPARATOR

Each participant will act as their own control by performing the 12 research tasks with and without the ARIA Device, using their long cane as they choose in both conditions. The control arm will be the participant's ordinary/preferred practice undertaking each task, referred to as non-ARIA.

Device: ARIA Glasses ( Augmented Reality in Audio )

Interventions

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.

With ARIA Glasses; Without ARIA Glasses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Independent long cane traveller.
• Sufficient hearing for conversation, with no hearing aids and no worse than mild to moderate hearing loss.
• Smartphone skills and familiarity with at least one app/device useful for wayfinding.
• Able to attend 4 research sessions in person at the investigation site in Haymarket, Sydney.
• Able to comply with all investigational requirements.

You may not qualify if:

• 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
• No smartphone skills or prior use of assistive technology.
• Unwilling to be videoed during research tasks.
• Unlikely to attend all follow-up study visits.

Sponsors & Collaborators

• ARIA Research Pty Ltd: lead
• University of Sydney: collaborator

Study Sites (1)

ARIA Research

Sydney, New South Wales, 2000, Australia

RECRUITING

MeSH Terms

Conditions

Blindness; Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lil Deverill, PhD

  Director of Clinical Trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Warren R Bingham

CONTACT

+61421 438 535; warren@ariaresearch.com.au

Lil Deverill, PhD

CONTACT

+61421 438 535; lil@ariaresearch.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Inter-rater reliability checks will be undertaken during the study to compare sensor-based and manual methods of recording trial times and travel distances The control arm will be the participant's ordinary/preferred practice undertaking each task, referred to as non-ARIA.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 27, 2024
• Study Start: July 29, 2024
• Primary Completion: October 28, 2024
• Study Completion: December 21, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)