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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- ARIA Device Safety
研究概览
简要总结
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.
详细描述
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.
Intervention Name: The ARIA Device
Why: This study broadly asks: What is the ARIA difference, and how do we measure it? Aria Research is committed to codesign - developing assistive technology with and for people who are blind, so that the resulting device has genuine utility.
This pilot study explores the ARIA difference by comparing the performance of blind adults on 12 different research tasks that were codesigned with blind adults to represent their everyday tasks and environments. Each participant serves as their own control, undertaking each task with and without the Aria Device. This embedded mixed methods study has a qualitative priority. Checking the relevance of tasks and measures with every participant is part of warranting the validity of measurement data and the transferability/generalisability of study findings.
What: Materials for this study include the prototype ARIA Device being investigated, and the research resources that provide context for the investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
ARIA Device Safety
时间窗: 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
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).
次要结局
- Secondary outcomes include efficacy endpoints, usability endpoints and exploratory endpoints.(Through study completion, an average of 1 year)