<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04427631</url>
  </required_header>
  <id_info>
    <org_study_id>262816</org_study_id>
    <nct_id>NCT04427631</nct_id>
  </id_info>
  <brief_title>Exploring Interventions for Glue Ear During Covid-19</brief_title>
  <acronym>BIG-C</acronym>
  <official_title>Exploring Interventions for Children With Chronic Otitis Media With Effusion ('Glue Ear') When Services Are Reduced During Covid-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridgeshire Community Services NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridgeshire Community Services NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the Coronavirus pandemic children's hearing services are closed or reduced and grommet&#xD;
      operations are part of the lowest priority group. In the absence of management options, this&#xD;
      research study aims to see if bone conduction headphones either paired (via bluetooth) to a&#xD;
      microphone or an app will help children with a hearing loss during this period of waiting.&#xD;
      The child's quality of life is measured with validated questionnaires The study is over 3&#xD;
      months, and delivered remotely, with the product being sent to the family home and support&#xD;
      offered via telephone/ video consulattion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis&#xD;
&#xD;
      Transmission of speech aided by a wireless bone-conduction headphone connected to a wireless&#xD;
      Bluetooth microphone during the prolonged waiting time (during the coronavirus pandemic) for&#xD;
      the insertion of grommets, as well as access to the Hear Glue Ear software application is an&#xD;
      acceptable management strategy during the coronavirus period where other forms of treatment&#xD;
      and support are not available or indefinitely delayed. Questionnaires intend to capture data&#xD;
      regarding families perception of child quality of life and developmental outcomes with this&#xD;
      intervention.&#xD;
&#xD;
      Aim To quantify the differences in speech, language, and quality of life outcome measures&#xD;
      between a group of children aided with a bone-conduction headphone and Hearing Glue Ear app&#xD;
      during the coronavirus pandemic where usual care has been delayed such as waiting for grommet&#xD;
      insertion.&#xD;
&#xD;
      Participants A total of 20 children will be enrolled in the study. If drop outs occur, new&#xD;
      participants will be invited to replace those who withdrew from the study.&#xD;
&#xD;
      Participant recruitment Children known to Cambridge Audiology Services and known to have a&#xD;
      diagnosis of glue ear will be invited to take part in the study if they satisfy the inclusion&#xD;
      criteria. Consent will be obtained from their parents and an age appropriate explanation&#xD;
      given to the child with the chance for the child to sign an age- appropriate assent form.&#xD;
&#xD;
      Design The free Hear glue Ear software application will be referred to as 'the app' in this&#xD;
      section.&#xD;
&#xD;
      A single arm design will be used. Participants will have a glue ear (Otitis Media with&#xD;
      Effusion, OME) diagnosis made in the National Health Service Cambridge Audiology clinics.&#xD;
      They will be given information and invited to take part in the study at a time convenient to&#xD;
      them.&#xD;
&#xD;
      Participants in the Study will be sent the bone conduction headphones, microphone and details&#xD;
      of how to download the free Hear Glue Ear app. A member of the research team will arrange a&#xD;
      telephone/ video consultation to aid set up and use of the product set.&#xD;
&#xD;
      The parent/ carer will be asked to fill out a questionnaire about their child's listening,&#xD;
      language and quality of life before and after using the product set.&#xD;
&#xD;
      The bone conduction headphones used in this study are currently on the market as a headphones&#xD;
      used by people practising outdoor sports. It is a type of headphones designed for children&#xD;
      and adults to listen to music and speech via bluetooth to a phone or device. It is not a&#xD;
      medical device but has a Conformity marking of Europe (known as CE mark) for being used as a&#xD;
      set of headphones for any member of the public.&#xD;
&#xD;
      Follow-up will be carried out after 3 months unless the family request more frequent support.&#xD;
      A member of the research team will email or telephone or video- consult (depending on the&#xD;
      preference of the family) after 3 months to see if the family used the Hear Glue Ear&#xD;
      headphones and/ or app at home and gather feedback. Parents will be asked to complete&#xD;
      questionnaires again at this point.&#xD;
&#xD;
      The patient's family 'general practitioner' doctor will be informed (with parental consent)&#xD;
      if the child is involved in the research study. The child's inclusion in the research study&#xD;
      should not affect or alter any usual medical care.&#xD;
&#xD;
      Follow up will also be possible when the child attends their next NHS hearing test&#xD;
      appointment when services reopen after or during the coronavirus pandemic.&#xD;
&#xD;
      Timing of the study and practical aspects&#xD;
&#xD;
        1. Invitation to take part&#xD;
&#xD;
           The children and their families will be given a pack containing:&#xD;
&#xD;
             -  Parent and child study information sheets. The family and the child will have the&#xD;
                chance to ask initial questions about the study within the remote telephone/ video&#xD;
                clinic appointment.&#xD;
&#xD;
             -  Consent form, which the family can be encouraged to complete and return by email.&#xD;
&#xD;
           Quality of life questionnaire for children with Otitis Media known as OMQ14 Speech,&#xD;
           language and listening questionnaire.&#xD;
&#xD;
           Website address: http://hearglueear.wordpress.com (study details including copies of&#xD;
           consent forms and questionnaires will be available on the website) and contact email:&#xD;
&#xD;
           hearglueear@outlook.com (for the families to direct any queries).&#xD;
&#xD;
        2. Once the child has been recruited&#xD;
&#xD;
             -  The children and their family will be sent a bone conduction headphone, microphone&#xD;
                and information on how to download the free Hear Glue Ear app.&#xD;
&#xD;
             -  Participant's personal and contact details, as well as a copy of their last&#xD;
                audiology results will be assigned a code that will be used for data collection,&#xD;
                and their personal data and contact details will be kept separately.&#xD;
&#xD;
             -  Participating families will have a remote telephone/ video appointment offered at&#xD;
                the beginning of the study and 3 months after their involvement.&#xD;
&#xD;
        3. Three months after their first appointment All the children will be automatically&#xD;
           followed up with another telephone/ video consultation.&#xD;
&#xD;
      The family will be encouraged to fill out the final questionnaires, which are the same&#xD;
      validated questionnaires used at the beginning of the study (before the intervention) as well&#xD;
      as a non- validated acceptability questionnaire.&#xD;
&#xD;
      A website with videos, support information, instructions, and useful materials was created&#xD;
      for use of the participants: http://hearglueear.wordpress.com&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 22, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_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)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>It is too difficult to blind the assessor in thsi instance.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>acceptability of management strategy, questionnaire</measure>
    <time_frame>Acceptability will be measured on a Likert scale pre-assessment and the end of 3 months of using the intervention</time_frame>
    <description>questionnaire based accpetability question. A higher acceptability score will be positive for the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life questionnaire OMQ-14</measure>
    <time_frame>Questionnaires at beginning of study (as a baseline assessment and after 3 months of using the intervention. The sc</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hearing Impaired Children</condition>
  <condition>Glue Ear</condition>
  <condition>Hearing Loss, Conductive</condition>
  <arm_group>
    <arm_group_label>Single arm study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The family will complete questionnaires before and after each childs intervention. Therefore each child will act as their own control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bone conduction headphones</intervention_name>
    <description>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.</description>
    <arm_group_label>Single arm study</arm_group_label>
    <other_name>Hear Glue ear app (software application)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 3-11y&#xD;
&#xD;
          -  English used as a main language (since app is only written in English)&#xD;
&#xD;
          -  Glue ear with a hearing loss affecting at least 2 frequencies in at least one ear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age range outside the 3-11 y parameter&#xD;
&#xD;
          -  normal hearing&#xD;
&#xD;
          -  not using english as a main language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tamsin M Holland Brown, MBBS MRCPCH</last_name>
    <phone>07977160976</phone>
    <email>drtamsinhollandbrown@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>alison Sansome, MBBS MRCPCH</last_name>
    <phone>01223218072</phone>
    <email>alison.sansome@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peacock Children's centre. Brookfields Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB1 3DF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Tamsin M Holland Brown, MBBS MRCPCH</last_name>
      <phone>07977160976</phone>
      <email>drtamsinhollandbrown@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Alison Sansome, BM BCh MA MRCPCH</last_name>
      <phone>01223218072</phone>
      <email>alison.sansome@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridgeshire Community Services NHS Trust</investigator_affiliation>
    <investigator_full_name>Dr. Tamsin Brown</investigator_full_name>
    <investigator_title>Paediatrician and chief investigator</investigator_title>
  </responsible_party>
  <keyword>Covid</keyword>
  <keyword>OME</keyword>
  <keyword>Glue ear</keyword>
  <keyword>Otitis Media with effusion</keyword>
  <keyword>paediatric</keyword>
  <keyword>hearing loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Otitis Media with Effusion</mesh_term>
    <mesh_term>Hearing Loss, Conductive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>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)</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427631
org study id: 262816
nct id: NCT04427631
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: N/A
intervention model: Single Group Assignment
intervention 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)
primary purpose: Treatment
masking: None (Open Label)
masking description: It is too difficult to blind the assessor in thsi instance.
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
description: questionnaire based accpetability question. A higher acceptability score will be positive for the intervention.
measure: 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
description: 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.
arm group label: Single arm study
arm group type: Experimental
description: The family will complete questionnaires before and after each childs intervention. Therefore each child will act as their own control.
intervention type: Device
intervention name: Bone conduction headphones
description: 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.
arm group label: Single arm study
other name: Hear Glue ear app (software application)
criteria: 
gender: All
minimum age: 3 Years
maximum age: 11 Years
healthy volunteers: No
last name: Tamsin M Holland Brown, MBBS MRCPCH
phone: 07977160976
email: drtamsinhollandbrown@gmail.com
last name: alison Sansome, MBBS MRCPCH
phone: 01223218072
email: alison.sansome@nhs.net
facility: 
contact: 
contact backup: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cambridgeshire Community Services NHS Trust
investigator full name: Dr. Tamsin Brown
investigator title: Paediatrician and chief investigator
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Otitis Media with Effusion
mesh term: Hearing Loss, Conductive
sharing ipd: Undecided
ipd description: 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)