Vestibular schwannoma Ear, Nose and Throat
Conditions
Interventions
Participants will be asked to complete a number of hearing screening tests (otoscopy, tympanometry) and hearing-related outcome tests and questionnaires. The tests that will be included are as follows
Sponsors
Northern Care Alliance NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Being diagnosed with sporadic vestibular schwannoma (VS) and tumour size <25 mm in the cerebellopontine angle (CPA) 2. Being ‘treated’ for VS with either radiological surveillance (‘watch and wait’) or SRS 3. Adults aged 30 – 65 years old 4. Adults with a mild-to-severe (pure-tone average across five audiometric frequencies between 20 and 70 dB HL) sensorineural hearing loss in at least one ear 5. Opinion of the treating clinician is that the patient will be able to successfully complete the research protocol 6. Normal otoscopy results 7. Normal middle ear health and function 8. Agreeing to have any excessive ear wax removed by a qualified audiologist 9. Native English speaker
Exclusion criteria
Exclusion criteria: 1. Have profound hearing loss 2. Tumours >25 mm in the CPA 3. Have type II neurofibromatosis (NF2) 4. Are currently taking ototoxic medication, such as aminoglycosides, carboplatin, cisplatin or any platinum-based cancer medications 5. Previous CNS radiotherapy/SRS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Speech recognition thresholds from a preliminary cross-sectional group (25 to 30 patients from each intervention) will be measured once at baseline using digits-in-noise (DIN) testing with the variance (standard deviation) in DIN speech recognition thresholds reported as the primary outcome measure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The clinical feasibility of measuring the effects of treatment (observation vs intervention with stereotactic radiosurgery [SRS]) for VS on hearing function, measured using: 1.1. Patient recruitment rates at 12 months into the study 1.2. Time to complete all hearing tests (pure tone audiometry, digits-in-noise [monaural and antiphasic], Speech, Spatial and Qualities of hearing scale [SSQ], Tinnitus Functional Index [TFI]) 1.3. Rates of completion of all hearing tests (pure tone audiometry, digits-in-noise [monaural and antiphasic], Speech, Spatial and Qualities of hearing scale [SSQ], Tinnitus Functional Index [TFI]), measured at the end of the study 2. Important factors that will inform a future RCT, specifically: 2.1. Patient attrition rates, measured at the end of the study 2.2. The total number of patients who do not meet the inclusion criteria throughout the course of the study 2.3. Outcomes: time taken per participant to collect all study data | — |
Countries
England, United Kingdom
Contacts
Public ContactDaniel Lewis
Outcome results
None listed