Hearing Impaired ChildrenBIG-CNCT04427631
Exploring Interventions for Glue Ear During Covid-19
A study testing Bone conduction headphones in people with Hearing Impaired Children and Glue Ear, run by Cambridgeshire Community Services NHS Trust at 1 site in United Kingdom.
Trial summary
During the Coronavirus pandemic children's hearing services are closed or reduced and grommet operations are part of the lowest priority group. In the absence of management options, this research study aims to see if bone conduction headphones either paired (via bluetooth) to a microphone or an app will help children… Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Hearing Impaired Children, Glue Ear, Hearing Loss, Conductive
- What is being tested?
- Bone conduction headphones
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-11y
- English used as a main language (since app is only written in English)
- Glue ear with a hearing loss affecting at least 2 frequencies in at least one ear
Who cannot join
- age range outside the 3-11 y parameter
- normal hearing
- not using english as a main language
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Peacock Children's centre. Brookfields Hospital
Cambridge, Cambridgeshire, CB1 3DF
Tamsin M Holland Brown, MBBS MRCPCH, 07977160976, drtamsinhollandbrown@gmail.com
Alison Sansome, BM BCh MA MRCPCH, 01223218072, alison.sansome@nhs.net
About this study
Official title: Exploring Interventions for Children With Chronic Otitis Media With Effusion ('Glue Ear') When Services Are Reduced During Covid-19
During the Coronavirus pandemic children's hearing services are closed or reduced and grommet operations are part of the lowest priority group. In the absence of management options, this research study aims to see if bone conduction headphones either paired (via bluetooth) to a microphone or an app will help children with a hearing loss during this period of waiting. The child's quality of life is measured with validated questionnaires The study is over 3 months, and delivered remotely, with the product being sent to the family home and support offered via telephone/ video consulattion.
Read the detailed description
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
- 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).
- 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.
- 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
- Being tested
- Bone conduction headphones
- Keywords
- Covid, OME, Glue ear, Otitis Media with effusion, paediatric, hearing loss
- Medical subject headings
- Otitis Media with Effusion, Hearing Loss, Conductive, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone conduction headphonesDevice
Also called Hear Glue ear app (software application)
Children will be offered hearing support with bone conduction headphones that can either be paired to a microphone or to a tablet/ phone/ computer to help children to hear. The Hear Glue Ear app is available for free to provide speech and language enrichment.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | The family will complete questionnaires before and after each childs intervention. Therefore each child will act as their own control. Receives: Device: Bone conduction headphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability of management strategy, questionnaire
questionnaire based accpetability question. A higher acceptability score will be positive for the intervention.
Measured: Acceptability will be measured on a Likert scale pre-assessment and the end of 3 months of using the intervention
Secondary outcomes (1)
quality of life questionnaire OMQ-14
validated questionnaire assessing quality of life in children with glue ear. The questionnaire assess disease- related hearing difficulty and treatment-related improvements in hearing. Improved (lower) scores will indicate a more positive response from the intervention.
Measured: Questionnaires at beginning of study (as a baseline assessment and after 3 months of using the intervention. The sc
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start22 Jun 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm study offering all children with glue ear currently waiting on grommet operation lists, an invitation to be involved in this research study for hearing support (bone conduction headphones, a microphone and an app which can be delivered remotely)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridgeshire Community Services NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Dr. Tamsin Brown, Cambridgeshire Community Services NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427631
- Sponsor's protocol ID
- 262816
- Acronym
- BIG-C
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised individual patient data could be shared with other researchers as long as all personal information and details of a patients individual condition are unidentifiable (since it is a small study)
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Interventions for Children With Chronic Otitis Media With Effusion ('Glue Ear') When Services Are Reduced During Covid-19
- ClinicalTrials.gov ID
- NCT04427631
- Acronym / sponsor ID
- BIG-C / 262816
- Keywords
- Covid, OME, Glue ear, Otitis Media with effusion, paediatric, hearing loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cambridgeshire Community Services NHS TrustUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 22 Jun 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the Coronavirus pandemic children's hearing services are closed or reduced and grommet operations are part of the lowest priority group. In the absence of management options, this research study aims to see if bone conduction headphones either paired (via bluetooth) to a microphone or an app will help children with a hearing loss during this period of waiting. The child's quality of life is measured with validated questionnaires The study is over 3 months, and delivered remotely, with the product being sent to the family home and support offered via telephone/ video consulattion.
Detailed description
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
- 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).
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm study offering all children with glue ear currently waiting on grommet operation lists, an invitation to be involved in this research study for hearing support (bone conduction headphones, a microphone and an app which can be delivered remotely)
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Device: Bone conduction headphonesThe family will complete questionnaires before and after each childs intervention. Therefore each child will act as their own control. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 3-11y
- English used as a main language (since app is only written in English)
- Glue ear with a hearing loss affecting at least 2 frequencies in at least one ear
Key exclusion criteria (3 listed)
- age range outside the 3-11 y parameter
- normal hearing
- not using english as a main language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone conduction headphonesAlso: Hear Glue ear app (software application)Children will be offered hearing support with bone conduction headphones that can either be paired to a microphone or to a tablet/ phone/ computer to help children to hear. The Hear Glue Ear app is available for free to provide speech and language enrichment. | Device | Single arm study |
Primary outcome
acceptability of management strategy, questionnaire
Time frame: Acceptability will be measured on a Likert scale pre-assessment and the end of 3 months of using the intervention
questionnaire based accpetability question. A higher acceptability score will be positive for the intervention.
1 secondary outcome
quality of life questionnaire OMQ-14
Time frame: Questionnaires at beginning of study (as a baseline assessment and after 3 months of using the intervention. The sc
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: Undecided. Anonymised individual patient data could be shared with other researchers as long as all personal information and details of a patients individual condition are unidentifiable (since it is a small study)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone conduction headphones in people with Hearing Impaired Children and Glue Ear, run by Cambridgeshire Community Services NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamsin M Holland Brown, MBBS MRCPCH (07977160976, drtamsinhollandbrown@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptability of management strategy, questionnaire (time frame: Acceptability will be measured on a Likert scale pre-assessment and the end of 3 months of using the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.