Assessment of Patient Experience With Auto-Captioning Glasses in NF2-Related-Schwannomatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- System Usability Scale
研究概览
简要总结
The goal of this clinical trial is to investigate the usability of auto-captioning glasses for adults diagnosed with NF2-related schwannomatosis and loss of hearing. The primary objective of the study is to determine the feasibility and acceptability of auto-captioning glasses in this population.
Participants will be asked to:
- Use the glasses at their discretion for 12 weeks
- Report their feedback at 3 and 12 week timepoints via online surveys and remote qualitative interviews
详细描述
Patients with NF2-related schwannomatosis (NF2-SWN) often experience progressive hearing loss. The nature of their hearing loss frequently hinders the use of surgical or drug interventions. Due to this, assistive hearing technology such as speech to text machines are commonplace in this population. New technology such as augmented reality (AR) auto-captioning glasses are gaining popularity among deafened and hard of hearing participants for their ability to overlay live captions onto see-through lenses. The goal of this study is to investigate the feasibility and acceptability of this technology in the NF2-SWN population.
The investigators aim to achieve this goal by recruiting up to 20 adult participants with a diagnosis of NF2-SWN and a history of hearing loss to a single-arm, open pilot study. The participants will be provided with a pair of Captify auto-captioning glasses to use over a period of 12 weeks. The investigators will assess participant's use of and feedback of the device at a 3-week timepoint and at study completion.
At baseline, the investigators will enroll participants and obtain informed consent to participate. Patient background information will be collected at baseline alongside a short qualitative interview. After three weeks, participants will complete select patient-reported questionnaires to assess their feedback. After 12 weeks, the participants will again perform final surveys and follow-up interview, and return the glasses to clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Diagnosis of NF2-SWN by 2022 revised criteria
- •Age 18 years or older at time of consent
- •Willing and able to sign informed consent
- •Access to a mobile phone with current operating software (i.e., iOS 16+ or Android 12+) and an internet connection
- •Does not require prescription glasses to communicate others (e.g. may use reading glasses or similar)
- •Resident of the U.S.
- •English-speaking
排除标准
- •Current use of auto-captioning glasses
研究组 & 干预措施
Adults with NF2-SWN and Hearing Loss
Adults with a clinical diagnosis of NF2-SWN and self reported hearing loss will use the auto-captioning glasses for 12 weeks
干预措施: Auto-captioning Glasses (Device)
结局指标
主要结局
System Usability Scale
时间窗: 12 Weeks
Used to assess the usability of the auto-captioning glasses, scored from 0-100, with higher scores indicating higher usability.
次要结局
- Modified Telehealth Usability Questionnaire (Satisfaction and Future Use Sub-scale)(12 Weeks)
- Self-Reported Device Use(12 Weeks)
研究者
Vanessa Merker, PhD
Research Director, Family Center for Neurofibromatosis and Schwannomatosis
Massachusetts General Hospital
