Effects of treatment for vestibular schwannoma on hearing function
| ISRCTN | ISRCTN72586805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72586805 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 321428 |
| Protocol serial number | 22NEURO19-S, IRAS 321428, CPMS 56401 |
| Sponsor | Northern Care Alliance NHS Foundation Trust |
| Funder | NIHR Manchester Biomedical Research Centre (BRC) in Hearing Health |
- Submission date
- 03/01/2024
- Registration date
- 07/02/2024
- Last edited
- 04/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims:
Vestibular schwannomas (VS) are non-cancerous tumours that grow on the hearing and balance nerve. These tumours can cause problems such as hearing loss, ringing or other noises in the head (tinnitus) and loss of balance. Treatment options for VS depend on tumour size and how fast it is growing. Small tumours are usually monitored using MRI scans (i.e., ‘watch and wait’). Surgery may be needed to remove a large tumour or treat one that is growing. One type of treatment, stereotactic radiosurgery (SRS), uses a precise beam of radiation to arrest tumour growth. The ‘watch and wait’ treatment option presents a risk to hearing function as hearing often continues to deteriorate in the affected ear, even without obvious tumour growth. Some research studies suggest that stereotactic radiosurgery used at the time of tumour diagnosis, might delay hearing ability decline but the evidence is unclear. The aim of this study is to assess the viability of monitoring hearing function in people being managed for VS. The researchers want to understand which hearing function tests are best to evaluate the potential benefits of SRS compared with ‘watch and wait’. They also aim to measure the reliability of the hearing tests over time.
Who can participate?:
Patients between 30 and 65 years of age who have a sporadic vestibular schwannoma and are either undergoing follow-up with serial MRI scans or are being considered for/have undergone treatment with SRS
What does the study involve?
At the testing session the researchers will carry out five hearing tests and complete two questionnaires.
What are the possible benefits and risks of participating?
Overall the results of this feasibility study will be used to help us better understand hearing loss in VS and answer an important question. Taking part in this study will not disadvantage participant's usual treatment in any way. All the hearing tests being used in this study are accepted clinical tools and there is minimal-to-no-excess risk to participants taking part in this study.
Where is the study run from?
Northern Care Alliance NHS Foundation Trust and the University of Manchester (UK)
When is the study starting and how long is it expected to run for?
October 2022 to February 2025
Who is funding the study?
NIHR Manchester Biomedical Research Centre (BRC) in Hearing Health (UK)
Who is the main contact?
Dr Daniel Lewis, daniel.lewis-3@manchester.ac.uk
Contact information
Principal investigator
Department of Academic Neurosciences
Salford Royal Hospital
Manchester
M6 8HD
United Kingdom
 ORCID ID |
0000-0002-5083-9416 |
|---|---|
| Phone | +44 (0)161 789 7373 |
| omar.pathmanaban@manchester.ac.uk |
Public, Scientific
Department of Academic Neurosciences
Salford Royal Hospital
Manchester
M6 8HD
United Kingdom
| ORCID ID |
0000-0001-6831-6990 |
|---|---|
| Phone | +44 (0)161 789 7373 |
| daniel.lewis-3@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective single-centre non-randomized interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Effects of treatment for vestibular schwannoma on hearing function: a feasibility study |
| Study objectives | The primary aim of this pilot study is to determine the feasibility of using online hearing tests to monitor hearing function in participants with vestibular schwannoma (VS). Feasibility will be assessed via recruitment rates, completion rates and completion times for the full battery of hearing screening and hearing tests. |
| Ethics approval(s) |
Approved 07/07/2023, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8290; gmeast.rec@hra.nhs.uk), ref: 23/NW/0149 |
| Health condition(s) or problem(s) studied | Vestibular schwannoma |
| Intervention | 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: otoscopy, tympanometry, pure-tone audiometry (PTA), Arthur Boothroyd (AB) word test, digits-in-noise (DIN) testing, Speech and Spatial Qualities of hearing scale (SSQ) questionnaire, and Tinnitus Functional Index (TFI) questionnaire. A subset of participants (n = 30) will be asked to repeat the DIN tests to measure the test-retest reliability of this outcome. |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. The clinical feasibility of measuring the effects of treatment (observation vs intervention with stereotactic radiosurgery [SRS]) for VS on hearing function, measured using: |
| Completion date | 03/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 30 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/10/2023 |
| Date of final enrolment | 03/01/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Stott Lane
Salford
M6 8HD
United Kingdom
Ellen Wilkinson Building, Oxford Road
Manchester
M13 9PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Data used in the study will be available from the study coordinator (Dr Daniel Lewis, daniel.lewis-3@manchester.ac.uk) upon reasonable request with clear aims and respecting patient confidentiality. Individual patients will not be identifiable from any published data, tables or figures. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/03/2024: Internal review.
15/01/2024: Study's existence confirmed by the HRA.
