Exploring interventions over the watchful waiting period for children with hearing loss secondary to chronic otitis media with effusion (‘glue ear’)

Exploring interventions over the watchful waiting period for children with hearing loss secondary to chronic otitis media with effusion (‘glue ear’): a single-centre interventional randomised controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13818722

Enrollment

Registered

2015-10-16

Start date

2015-10-15

Completion date

Unknown

Last updated

2023-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic otitis media with effusion Ear, Nose and Throat Otitis media

Interventions

1. Study group: Participants (children) will wear a bone-conduction headset paired with a Bluetooth microphone. The microphone can be worn by a parent or a teacher. Children are expected to wear the d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 3 to 6 years 2. Diagnosed with non-infected chronic otitis media waiting for grommet insertion 3. Hearing loss should be 25 dB or more at three AC test frequencies. Unaided BC thresholds should be 10 dB or better

Exclusion criteria

Exclusion criteria: 1. Cleft palate 2. Risk factors for or diagnosis of sensorineural hearing loss, unrelated speech and/or language and/or communication disorders 3. Non-English dominant language, as this could affect the typical course of speech and language development, introducing a source of variability not related to middle-ear pathology

Design outcomes

Primary

Measure	Time frame
Speech and Language Development: DIFFERENTIAL SCORE (before/after) obtained from the outcomes of Preschool-age CELF (Clinical Evaluation of Language Fundamentals) and STAP (South Tyneside assessment of Phonology). The examiner is blinded as to which condition was assigned to each participant. "Before" and "after" are the timepoints at the start of the study (before the intervention) and at the end of the study (for most children between six and nine months after the beginning of the intervention). The data will be tested to check the assumptions of ANOVA (analysis of variance). If these assumptions (normal distribution and homogeneity of variance) are met then a one-way ANOVA with factor group and variate "differential score" will be performed for each outcome measure. If the assumptions of ANOVA are not met, a non-parametric test will be used. Data will be summarised by creating graphs. The scientist who will carry out the statistical analysis will remain blinded to the identity of the groups until the statistical analysis has been completed.	—

Measure

Time frame

Speech and Language Development: DIFFERENTIAL SCORE (before/after) obtained from the outcomes of Preschool-age CELF (Clinical Evaluation of Language Fundamentals) and STAP (South Tyneside assessment of Phonology). The examiner is blinded as to which condition was assigned to each participant. "Before" and "after" are the timepoints at the start of the study (before the intervention) and at the end of the study (for most children between six and nine months after the beginning of the intervention). The data will be tested to check the assumptions of ANOVA (analysis of variance). If these assumptions (normal distribution and homogeneity of variance) are met then a one-way ANOVA with factor group and variate "differential score" will be performed for each outcome measure. If the assumptions of ANOVA are not met, a non-parametric test will be used. Data will be summarised by creating graphs. The scientist who will carry out the statistical analysis will remain blinded to the identity of the groups until the statistical analysis has been completed.

—

Secondary

Measure	Time frame
Other measures: DIFFERENTIAL SCORE (before/after) obtained from the outcomes of the questionnaires (Strengths and Difficulties [quality of life], Conners [Attention Deficit and Hyperactivity Disorder], ABEL (Auditory Behaviour in Everyday Life) [Listening skills]. "Before" and "after" are the timepoints at the start of the study (before the intervention) and at the end of the study (for most children between six and nine months after the beginning of the intervention). Statistical analysis will be accomplished as described for the primary outcome measure.	—

Measure

Time frame

Other measures: DIFFERENTIAL SCORE (before/after) obtained from the outcomes of the questionnaires (Strengths and Difficulties [quality of life], Conners [Attention Deficit and Hyperactivity Disorder], ABEL (Auditory Behaviour in Everyday Life) [Listening skills]. "Before" and "after" are the timepoints at the start of the study (before the intervention) and at the end of the study (for most children between six and nine months after the beginning of the intervention). Statistical analysis will be accomplished as described for the primary outcome measure.

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Countries

England, United Kingdom

Contacts

Public ContactTamsin Brown

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026