Condition category
Ear, Nose and Throat
Date applied
14/10/2015
Date assigned
16/10/2015
Last edited
05/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

https://hearglueear.wordpress.com

Contact information

Type

Public

Primary contact

Dr Tamsin Brown

ORCID ID

http://orcid.org/0000-0003-0745-8877

Contact details

Community Child Health
Block 13
Ida Darwin Hospital
Fulbourn
Cambridge
CB21 5EE
United Kingdom

Type

Scientific

Additional contact

Dr Marina Salorio-Corbetto

ORCID ID

Contact details

Chear Ltd.
30 Fowlmere Road
Shepreth
Royston
Herts
SG8 6QS
United Kingdom
+44(0)1783263333
marina@chears.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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.

Acronym

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

Black Country NRES Committee, 13/01/2016, ref: 15/WM/0438

Study design

Single-centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/11/2014

Overall trial end date

01/11/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

30

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

14/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridgeshire Community Services (CCS)
Block 13, Ida Darwin Hospital Fulbourn
Cambridge
CB21 5EE
United Kingdom

Trial participating centre

Chear Ltd.
30 Fowlmere Road Shepreth
Royston, Herts
SG8 6QS
United Kingdom

Sponsor information

Organisation

Cambridge Hearing Trust

Sponsor details

34 Butchers Hill
Ickleton
Saffron Walden
Essex
CB10 1SR
United Kingdom

Sponsor type

Charity

Website

Organisation

Health Enterprise East

Sponsor details

Milton Hall
Ely Road
Milton
Cambridge
CB24 6WZ
United Kingdom
+44 (0)1223 928040
enquiries@hee.co.uk

Sponsor type

Other

Website

http://www.hee.org.uk

Organisation

British Society of Audiology

Sponsor details

80 Brighton Road
Reading
RG6
United Kingdom
+44 (0)118 966 0622
bsa@thebsa.org.uk

Sponsor type

Charity

Website

www.thebsa.org.uk

Organisation

Health Education East of England (HEEoE)

Sponsor details

2-4 Victoria House
Capital Park
Fulbourn
Cambridge
CB21 5XB
United Kingdom
+44(0)1223 597500
midlandsandeast.comms@nhs.net

Sponsor type

Hospital/treatment centre

Website

www.eoe.hee.nhs.uk

Funders

Funder type

Government

Funder name

Health Education East of England, HEEoE

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

British Society of Audiology Applied Research Grant in Honour of Stuart Gatehouse

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cambridge Hearing Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/04/2016: Ethics approval information added.