Exploring Interventions for Glue Ear During Covid-19

Hypothesis

Transmission of speech aided by a wireless bone-conduction headphone connected to a wireless
Bluetooth microphone during the prolonged waiting time (during the coronavirus pandemic) for
the insertion of grommets, as well as access to the Hear Glue Ear software application is an
acceptable management strategy during the coronavirus period where other forms of treatment
and support are not available or indefinitely delayed. Questionnaires intend to capture data
regarding families perception of child quality of life and developmental outcomes with this
intervention.

Aim To quantify the differences in speech, language, and quality of life outcome measures
between a group of children aided with a bone-conduction headphone and Hearing Glue Ear app
during the coronavirus pandemic where usual care has been delayed such as waiting for grommet
insertion.

Participants A total of 20 children will be enrolled in the study. If drop outs occur, new
participants will be invited to replace those who withdrew from the study.

Participant recruitment Children known to Cambridge Audiology Services and known to have a
diagnosis of glue ear will be invited to take part in the study if they satisfy the inclusion
criteria. Consent will be obtained from their parents and an age appropriate explanation
given to the child with the chance for the child to sign an age- appropriate assent form.

Design The free Hear glue Ear software application will be referred to as 'the app' in this
section.

A single arm design will be used. Participants will have a glue ear (Otitis Media with
Effusion, OME) diagnosis made in the National Health Service Cambridge Audiology clinics.
They will be given information and invited to take part in the study at a time convenient to
them.

Participants in the Study will be sent the bone conduction headphones, microphone and details
of how to download the free Hear Glue Ear app. A member of the research team will arrange a
telephone/ video consultation to aid set up and use of the product set.

The parent/ carer will be asked to fill out a questionnaire about their child's listening,
language and quality of life before and after using the product set.

The bone conduction headphones used in this study are currently on the market as a headphones
used by people practising outdoor sports. It is a type of headphones designed for children
and adults to listen to music and speech via bluetooth to a phone or device. It is not a
medical device but has a Conformity marking of Europe (known as CE mark) for being used as a
set of headphones for any member of the public.

Follow-up will be carried out after 3 months unless the family request more frequent support.
A member of the research team will email or telephone or video- consult (depending on the
preference of the family) after 3 months to see if the family used the Hear Glue Ear
headphones and/ or app at home and gather feedback. Parents will be asked to complete
questionnaires again at this point.

The patient's family 'general practitioner' doctor will be informed (with parental consent)
if the child is involved in the research study. The child's inclusion in the research study
should not affect or alter any usual medical care.

Follow up will also be possible when the child attends their next NHS hearing test
appointment when services reopen after or during the coronavirus pandemic.

Timing of the study and practical aspects

1. Invitation to take part

The children and their families will be given a pack containing:

- Parent and child study information sheets. The family and the child will have the
chance to ask initial questions about the study within the remote telephone/ video
clinic appointment.

- Consent form, which the family can be encouraged to complete and return by email.

Quality of life questionnaire for children with Otitis Media known as OMQ14 Speech,
language and listening questionnaire.

Website address: http://hearglueear.wordpress.com (study details including copies of
consent forms and questionnaires will be available on the website) and contact email:

hearglueear@outlook.com (for the families to direct any queries).

2. Once the child has been recruited

- The children and their family will be sent a bone conduction headphone, microphone
and information on how to download the free Hear Glue Ear app.

- Participant's personal and contact details, as well as a copy of their last
audiology results will be assigned a code that will be used for data collection,
and their personal data and contact details will be kept separately.

- Participating families will have a remote telephone/ video appointment offered at
the beginning of the study and 3 months after their involvement.

3. Three months after their first appointment All the children will be automatically
followed up with another telephone/ video consultation.

The family will be encouraged to fill out the final questionnaires, which are the same
validated questionnaires used at the beginning of the study (before the intervention) as well
as a non- validated acceptability questionnaire.

A website with videos, support information, instructions, and useful materials was created
for use of the participants: http://hearglueear.wordpress.com