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Exploring Interventions for Glue Ear During Covid-19 (BIG-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04427631
Recruitment Status : Not yet recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Dr. Tamsin Brown, Cambridgeshire Community Services NHS Trust

Brief 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 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.

Condition or disease Intervention/treatment Phase
Hearing Impaired Children Glue Ear Hearing Loss, Conductive Device: Bone conduction headphones Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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)
Masking: None (Open Label)
Masking Description: It is too difficult to blind the assessor in thsi instance.
Primary Purpose: Treatment
Official Title: Exploring Interventions for Children With Chronic Otitis Media With Effusion ('Glue Ear') When Services Are Reduced During Covid-19
Estimated Study Start Date : June 22, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm study
The family will complete questionnaires before and after each childs intervention. Therefore each child will act as their own control.
Device: Bone conduction headphones
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.
Other Name: Hear Glue ear app (software application)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • age range outside the 3-11 y parameter
  • normal hearing
  • not using english as a main language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04427631


Contacts
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Contact: Tamsin M Holland Brown, MBBS MRCPCH 07977160976 drtamsinhollandbrown@gmail.com
Contact: alison Sansome, MBBS MRCPCH 01223218072 alison.sansome@nhs.net

Locations
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United Kingdom
Peacock Children's centre. Brookfields Hospital
Cambridge, Cambridgeshire, United Kingdom, CB1 3DF
Contact: Tamsin M Holland Brown, MBBS MRCPCH    07977160976    drtamsinhollandbrown@gmail.com   
Contact: Alison Sansome, BM BCh MA MRCPCH    01223218072    alison.sansome@nhs.net   
Sponsors and Collaborators
Cambridgeshire Community Services NHS Trust
Cambridge University Hospitals NHS Foundation Trust
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Responsible Party: Dr. Tamsin Brown, Paediatrician and chief investigator, Cambridgeshire Community Services NHS Trust
ClinicalTrials.gov Identifier: NCT04427631    
Other Study ID Numbers: 262816
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan 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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Tamsin Brown, Cambridgeshire Community Services NHS Trust:
Covid
OME
Glue ear
Otitis Media with effusion
paediatric
hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Otitis Media with Effusion
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Otitis Media
Otitis