Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:07 PM
Study NCT ID:
NCT07420751
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Patient Experience With Auto-Captioning Glasses in NF2-Related-Schwannomatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D016518', 'term': 'Neurofibromatosis 2'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009464', 'term': 'Neuroma, Acoustic'}, {'id': 'D009442', 'term': 'Neurilemmoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017253', 'term': 'Neurofibromatoses'}, {'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009463', 'term': 'Neuroma'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D000160', 'term': 'Vestibulocochlear Nerve Diseases'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale', 'timeFrame': '12 Weeks', 'description': 'Used to assess the usability of the auto-captioning glasses, scored from 0-100, with higher scores indicating higher usability.'}], 'secondaryOutcomes': [{'measure': 'Modified Telehealth Usability Questionnaire (Satisfaction and Future Use Sub-scale)', 'timeFrame': '12 Weeks', 'description': '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'}, {'measure': 'Self-Reported Device Use', 'timeFrame': '12 Weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NF2-SWN', 'Hearing Loss', 'Auto-captioning glasses', 'Augmented Reality', 'NF2', 'Neurofibromatosis Type II', 'Neurofibromatosis Type 2'], 'conditions': ['NF2-related Schwannomatosis']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants will be asked to:\n\n* Use the glasses at their discretion for 12 weeks\n* Report their feedback at 3 and 12 week timepoints via online surveys and remote qualitative interviews', 'detailedDescription': "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.\n\nThe 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.\n\nAt 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of NF2-SWN by 2022 revised criteria\n* Age 18 years or older at time of consent\n* Willing and able to sign informed consent\n* Access to a mobile phone with current operating software (i.e., iOS 16+ or Android 12+) and an internet connection\n* Does not require prescription glasses to communicate others (e.g. may use reading glasses or similar)\n* Resident of the U.S.\n* English-speaking\n\nExclusion Criteria:\n\n* Current use of auto-captioning glasses'}, 'identificationModule': {'nctId': 'NCT07420751', 'briefTitle': 'Assessment of Patient Experience With Auto-Captioning Glasses in NF2-Related-Schwannomatosis', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Assessment of Patient Experience With Auto-Captioning Glasses in NF2-Related-Schwannomatosis', 'orgStudyIdInfo': {'id': '2025P003439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adults with NF2-SWN and Hearing Loss', 'description': 'Adults with a clinical diagnosis of NF2-SWN and self reported hearing loss will use the auto-captioning glasses for 12 weeks', 'interventionNames': ['Device: Auto-captioning Glasses']}], 'interventions': [{'name': 'Auto-captioning Glasses', 'type': 'DEVICE', 'description': 'Augmented reality glasses that overlay real time captioning on see-through lenses, allowing users to read what is being said out loud.', 'armGroupLabels': ['Adults with NF2-SWN and Hearing Loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paulina Arias Hernandez, MSW', 'role': 'CONTACT', 'email': 'pahernandez@mgb.org'}, {'name': 'Vanessa Merker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'David G Bonilla, Sc.B', 'role': 'CONTACT', 'email': 'dbonilla2@mgh.harvard.edu', 'phone': '6319420682'}], 'overallOfficials': [{'name': 'Vanessa Merker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Director, Family Center for Neurofibromatosis and Schwannomatosis', 'investigatorFullName': 'Vanessa Merker, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}