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
|Condition or disease||Intervention/treatment||Phase|
|Hearing Impaired Children Glue Ear Hearing Loss, Conductive||Device: Bone conduction headphones||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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.|
|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|
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)
- 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.
- 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.
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
|Contact: Tamsin M Holland Brown, MBBS MRCPCHemail@example.com|
|Contact: alison Sansome, MBBS MRCPCHfirstname.lastname@example.org|
|Peacock Children's centre. Brookfields Hospital|
|Cambridge, Cambridgeshire, United Kingdom, CB1 3DF|
|Contact: Tamsin M Holland Brown, MBBS MRCPCH 07977160976 email@example.com|
|Contact: Alison Sansome, BM BCh MA MRCPCH 01223218072 firstname.lastname@example.org|