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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale | Used to assess the usability of the auto-captioning glasses, scored from 0-100, with higher scores indicating higher usability. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Weeks |
| Self-Reported Device Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Merker, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D016518 | Neurofibromatosis 2 |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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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 |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009464 | Neuroma, Acoustic |
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009463 | Neuroma |
| D009386 | Neoplastic Syndromes, Hereditary |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |