Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06477809




Registration number
NCT06477809
Ethics application status
Date submitted
3/06/2024
Date registered
27/06/2024
Date last updated
27/06/2024

Titles & IDs
Public title
A Pilot Study Comparing Performance of Blind Participants on 12 Tasks, With and Without the ARIA Device
Scientific title
A Controlled, Open Label Pilot Study to Assess the Safety, Efficacy, and Usability of the ARIA Device With Blind Individuals Who Have no Light Perception or Light Perception Only
Secondary ID [1] 0 0
CIP-01-ARIA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blindness and Low Vision 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ARIA Glasses ( Augmented Reality in Audio )

Active comparator: With ARIA Glasses - 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.

Active comparator: Without ARIA Glasses - 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.


Treatment: Devices: ARIA Glasses ( Augmented Reality in Audio )
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ARIA Device Safety
Timepoint [1] 0 0
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 [1] 0 0
Secondary outcomes include efficacy endpoints, usability endpoints and exploratory endpoints.
Timepoint [1] 0 0
Through study completion, an average of 1 year

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/12/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ARIA Research - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ARIA Research Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06477809
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lil Deverill, PhD
Address 0 0
Director of Clinical Trials
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Warren R Bingham
Address 0 0
Country 0 0
Phone 0 0
+61421 438 535
Fax 0 0
Email 0 0
warren@ariaresearch.com.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06477809