Exploring interventions over the watchful waiting period for children with hearing loss secondary to chronic otitis media with effusion (‘glue ear’)
| ISRCTN | ISRCTN13818722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13818722 |
| Secondary identifying numbers | N/A |
- Submission date
- 14/10/2015
- Registration date
- 16/10/2015
- Last edited
- 07/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims
Glue ear, or chronic otitis media with effusion (OME) is a medical condition often seen in childhood where the middle ear becomes filled with fluid. The main symptom is hearing loss. Children with OME are at risk of educational and communication difficulties, self-esteem and behavioural problems, and lower quality of life when compared to other children. The current guidelines for care, as established by NICE, are that these children are monitored with ‘watchful waiting’ and advice until grommets (also known as ‘ventilation tubes’) are inserted or hearing aids considered. Our hypothesis is that transmission of speech aided by a wireless bone-conduction headset (a headset designed so that sound is conducted through the bones of the skull) connected to a wireless Bluetooth microphone during the waiting time for the insertion of grommets improves speech and language and other developmental outcomes. The aim of this study is to measure the differences in speech, language, and quality of life between a group of children given a bone-conduction headset while waiting for grommet insertion, and a group of children that are not.
Who can participate?
Children aged 3-6 with glue ear and waiting for treatment with grommets.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 (study group) are given a bone-conduction headset paired with a Bluetooth microphone. Those in group 2 (control group) are given listening-based electronic games as an alternative activity. Each child’s speech and language development, quality of life and listening skills are measured before the start of the study and after treatment (between six and nine months later).
What are the possible benefits and risks of participating?
Benefits to participants include having access to more information about their hearing, since they will have a more thorough hearing test (such as determining listening levels in a noisy environment) and a speech and language assessment. They will all have web-based access to resources and information about glue ear which they would not otherwise have. They will all have petrol costs reimbursed and a small gift for each child participating will be given (under the value of £5 per child). Additionally , those children in the control group of the study will have access to computer games/apps which have been made to aid development of listening and auditory processing skills. Those children in the study group will benefit from wearing a bone conduction headset which will be linked to a microphone that can be worn by their teacher, or their parent, or their speech and language therapist, for up to 4 hours a day. They will benefit from having access to clear speech sounds which will be transferred through the child's cheekbones to the inner part of the child's ear, by-passing the middle part of the ear which is affected by the glue ear. The risks would be if the child found the device uncomfortable or felt there was a stigma attached to wearing it, or if the child managed to self adjust the hidden volume button and make sounds too loud.
Where is the study run from?
Cambridgeshire Community Services (CCS) and Chear Ltd. (an independent organisation for assessment and management of hearing)
When is the study starting and how long is it expected to run for?
October 2015 to October 2016
Who is funding the study?
1. Health Education,East of England
2. British Society of Audiology Applied Research Grant in Honour of Stuart Gatehouse
3. Cambridge Hearing Trust
Who is the main contact?
1. Tamsin Brown (public)
2. Dr Marina Salorio-Corbetto (scientific)
marina@chears.co.uk
Contact information
Public
Community Child Health
Block 13, Ida Darwin Hospital
Fulbourn
Cambridge
CB21 5EE
United Kingdom
 ORCID ID |
0000-0003-0745-8877 |
|---|
Scientific
Chear Ltd.
30 Fowlmere Road
Shepreth
Royston, Herts
SG8 6QS
United Kingdom
| Phone | +44(0)1783263333 |
|---|---|
| marina@chears.co.uk |
Study information
| Study design | Single-centre interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Exploring interventions over the watchful waiting period for children with hearing loss secondary to chronic otitis media with effusion (‘glue ear’): a single-centre interventional randomised controlled trial. |
| Study hypothesis | Transmission of speech aided by a wireless bone-conduction headphone connected to a wireless Bluetooth microphone during the waiting time for the insertion of grommets improves speech and language and other developmental outcomes. |
| Ethics approval(s) | Black Country NRES Committee, 13/01/2016, ref: 15/WM/0438 |
| Condition | Chronic otitis media with effusion |
| Intervention | 1. Study group: Participants (children) will wear a bone-conduction headset paired with a Bluetooth microphone. The microphone can be worn by a parent or a teacher. Children are expected to wear the device for four hours daily. 2. Control group: Participants will be presented with an alternative activity in order to control for performance bias. The activity is the use of listening-based electronic games (applications). Groups are blinded as to which is the control and the experimental condition. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bone-conduction headset paired with a Bluetooth microphone |
| Primary outcome measure | Speech and Language Development: DIFFERENTIAL SCORE (before/after) obtained from the outcomes of Preschool-age CELF (Clinical Evaluation of Language Fundamentals) and STAP (South Tyneside assessment of Phonology). The examiner is blinded as to which condition was assigned to each participant. "Before" and "after" are the timepoints at the start of the study (before the intervention) and at the end of the study (for most children between six and nine months after the beginning of the intervention). The data will be tested to check the assumptions of ANOVA (analysis of variance). If these assumptions (normal distribution and homogeneity of variance) are met then a one-way ANOVA with factor group and variate "differential score" will be performed for each outcome measure. If the assumptions of ANOVA are not met, a non-parametric test will be used. Data will be summarised by creating graphs. The scientist who will carry out the statistical analysis will remain blinded to the identity of the groups until the statistical analysis has been completed. |
| Secondary outcome measures | Other measures: DIFFERENTIAL SCORE (before/after) obtained from the outcomes of the questionnaires (Strengths and Difficulties [quality of life], Conners [Attention Deficit and Hyperactivity Disorder], ABEL (Auditory Behaviour in Everyday Life) [Listening skills]. "Before" and "after" are the timepoints at the start of the study (before the intervention) and at the end of the study (for most children between six and nine months after the beginning of the intervention). Statistical analysis will be accomplished as described for the primary outcome measure. |
| Overall study start date | 01/11/2014 |
| Overall study end date | 30/09/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 19 |
| Participant inclusion criteria | 1. Aged 3 to 6 years 2. Diagnosed with non-infected chronic otitis media waiting for grommet insertion 3. Hearing loss should be 25 dB or more at three AC test frequencies. Unaided BC thresholds should be 10 dB or better |
| Participant exclusion criteria | 1. Cleft palate 2. Risk factors for or diagnosis of sensorineural hearing loss, unrelated speech and/or language and/or communication disorders 3. Non-English dominant language, as this could affect the typical course of speech and language development, introducing a source of variability not related to middle-ear pathology |
| Recruitment start date | 15/10/2015 |
| Recruitment end date | 28/02/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Fulbourn
Cambridge
CB21 5EE
United Kingdom
Shepreth
Royston, Herts
SG8 6QS
United Kingdom
Sponsor information
Charity
34 Butchers Hill
Ickleton
Saffron Walden
CB10 1SR
United Kingdom
Other
Milton Hall
Ely Road, Milton
Cambridge
CB24 6WZ
United Kingdom
| Phone | +44 (0)1223 928040 |
|---|---|
| enquiries@hee.co.uk | |
| Website | http://www.hee.org.uk |
Charity
80 Brighton Road
Reading
RG6
United Kingdom
| Phone | +44 (0)118 966 0622 |
|---|---|
| bsa@thebsa.org.uk | |
| Website | www.thebsa.org.uk |
"ROR" |
https://ror.org/0597vc250 |
Hospital/treatment centre
2-4 Victoria House
Capital Park
Fulbourn
Cambridge
CB21 5XB
England
United Kingdom
| Phone | +44(0)1223 597500 |
|---|---|
| midlandsandeast.comms@nhs.net | |
| Website | www.eoe.hee.nhs.uk |
Funders
Funder type
Government
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish at the end of the trial in a well known medical peer reviewed journal. Additionally as part of the funding agreement with the BSA (British Society of Audiology) we, as the team agreed to present at a BSA conference or national meeting. We also intend to do this at the BAPA (British Association of Paediatricians in Audiology) annual conference. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Marina Salorio-Corbetto Marina@chears.co.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2019 | 04/06/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/06/2023: Internal review.
04/06/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
11/01/2018: The overall trial end date has been updated from 01/11/2016 to 30/09/2018. The recruitment end date has been updated from 14/10/2016 to 28/02/2018. The participant level sharing statement has been added.
05/04/2016: Ethics approval information added.
