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

April 23, 2026 updated by: Vanessa Merker, PhD, Massachusetts General Hospital

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Current use of auto-captioning glasses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Auto-captioning Glasses
Augmented reality glasses that overlay real time captioning on see-through lenses, allowing users to read what is being said out loud.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: 12 Weeks
Used to assess the usability of the auto-captioning glasses, scored from 0-100, with higher scores indicating higher usability.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Telehealth Usability Questionnaire (Satisfaction and Future Use Sub-scale)
Time Frame: 12 Weeks
Used to measure user satisfaction with the intervention, with individual items scored on a scale of 1-7 where higher numbers are more satisfactory; total score is an average of each item in the sub-scale
12 Weeks
Self-Reported Device Use
Time Frame: 12 Weeks
Participants will be asked whether they have used the device in the prior week, we will report the frequency (n) and percentage (%) of participants who report positively.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Vanessa Merker, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P003439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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