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NCT Number: NCT07420751

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

NF2-related Schwannomatosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Genetic Diseases, Inborn Hearing Disorders Hearing Loss Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurilemmoma Neurocutaneous Syndromes Neurodegenerative Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibromatoses Neurofibromatosis 2 Neurologic Manifestations Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathological Conditions, Signs and Symptoms Retrocochlear Diseases Sensation Disorders Signs and Symptoms Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auto-captioning Glasses

Device

Augmented reality glasses that overlay real time captioning on see-through lenses, allowing users to read what is being said out loud.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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