NF2-related SchwannomatosisNCT07420751
Assessment of Patient Experience With Auto-Captioning Glasses in NF2-Related-Schwannomatosis
A study testing Auto-captioning Glasses in people with NF2-related Schwannomatosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NF2-related Schwannomatosis
- What is being tested?
- Auto-captioning Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to 6 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current use of auto-captioning glasses
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
Read the 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.
- Conditions
- NF2-related Schwannomatosis
- Being tested
- Auto-captioning Glasses
- Keywords
- NF2-SWN, Hearing Loss, Auto-captioning glasses, Augmented Reality, NF2, Neurofibromatosis Type II, Neurofibromatosis Type 2
- Medical subject headings
- Hearing Loss, Neurofibromatosis 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-captioning GlassesDevice
Augmented reality glasses that overlay real time captioning on see-through lenses, allowing users to read what is being said out loud.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Auto-captioning Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
Used to assess the usability of the auto-captioning glasses, scored from 0-100, with higher scores indicating higher usability.
Measured: 12 Weeks
Secondary outcomes (2)
Modified Telehealth Usability Questionnaire (Satisfaction and Future Use Sub-scale)
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
Measured: 12 Weeks
Self-Reported Device Use
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start19 Feb 2026
- Primary completion6 Aug 2026
- Study completion6 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NF2-related SchwannomatosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Merker, PhD, Massachusetts General Hospital
- Investigators
- Vanessa Merker, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420751
- Sponsor's protocol ID
- 2025P003439
- Status last verified
- Aug 2026
- First submitted
- 12 Feb 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Experience With Auto-Captioning Glasses in NF2-Related-Schwannomatosis
- ClinicalTrials.gov ID
- NCT07420751
- Acronym / sponsor ID
- 2025P003439
- Conditions
- NF2-related Schwannomatosis
- Keywords
- NF2-SWN, Hearing Loss, Auto-captioning glasses, Augmented Reality, NF2, Neurofibromatosis Type II, Neurofibromatosis Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 6 Aug 2026 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with NF2-SWN and Hearing Loss | Experimental | Device: Auto-captioning GlassesAdults with a clinical diagnosis of NF2-SWN and self reported hearing loss will use the auto-captioning glasses for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Current use of auto-captioning glasses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-captioning GlassesAugmented reality glasses that overlay real time captioning on see-through lenses, allowing users to read what is being said out loud. | Device | Adults with NF2-SWN and Hearing Loss |
Primary outcome
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.
2 secondary outcomes
Modified Telehealth Usability Questionnaire (Satisfaction and Future Use Sub-scale)
Time frame: 12 Weeks
Self-Reported Device Use
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Merker, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-captioning Glasses in people with NF2-related Schwannomatosis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.