A Pilot Study Comparing Performance of Blind Participants on 12 Tasks, With and Without the ARIA Device
NCT Number: NCT06477809
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Blindness and Low Vision
Interventions: DEVICE: ARIA Glasses ( Augmented Reality in Audio )
Sponsor: ARIA Research Pty Ltd
Collaborators: University of Sydney
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-29
Completion Date: 2024-12-21
Locations: ARIA Research, Sydney, New South Wales, 2000, Australia

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.

Primary Outcome Measures: 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 Outcome Measures: 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., Through study completion, an average of 1 year