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临床试验/NCT07420751
NCT07420751已完成不适用

Assessment of Patient Experience With Auto-Captioning Glasses in NF2-Related-Schwannomatosis

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年2月19日最近更新:
适应症
干预措施

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vanessa Merker, PhD

Research Director, Family Center for Neurofibromatosis and Schwannomatosis

Massachusetts General Hospital

研究点 (1)

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