Clinical Trial: FM Systems on Children With Auditory Processing Disorders

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Effects of Frequency Modulation (FM) Assistive Listening Device Systems on Listening and Related Skills in Children With Auditory Processing Disorders (APD)

Brief Summary:

Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer, middle, inner) are normal but the person has difficulty identifying or discriminating sounds (Dawes & Bishop, 2009) and experiences listening difficulties in noise. Personal Frequency Modulation (FM) systems are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient noise, distance from speaker and reverberation are reduced (Keith & Purdy, 2014).

The principal research question is whether FM systems improve auditory attention, listening in noise performance and listening in spatialised noise in children with Auditory Processing Disorder (APD) in relation to just auditory training alone. We hypothesize that the FM system will lead to improved attention scores, improved speech in noise perception (aided and unaided) and improved ability to listen in spatialised noise that after prolonged FM use (6 months). Additionally, we hypothesise that these results will correlate with questionnaires (filled out by parents, teachers and children).

Thirty (30) children with a diagnosis of an APD from the Great Ormond Street Hospital Audiology clinic will be recruited. The children need to fulfil the following criteria:

1. Diagnosis of APD (based on routine clinical tests at GOSH):

   1. Abnormal performance on the auditory figure ground test (a speech in noise test) of the SCAN-C (i.e. at the 1st percentile score as per UK norms), or in the High-Cue or Low-Cue score of the LiSN-S test and
   2. Abnormal performance i
      

      Detailed Summary:

      Background and justification of the study Auditory Processing Disorder Auditory Processing Disorder (APD) is a disorder where the functions of the ear (outer, middle, inner) are normal but the person has difficulty identifying or discriminating sounds (Dawes & Bishop, 2009). For children with APD it is particularly difficult to hear when the listening conditions are not ideal. For example, when there is background noise it becomes really challenging to focus on the speaker. Two other factors that influence their hearing ability are reverberation and the distance from the speaker (Keith & Purdy, 2014).

      Moreover, there are studies which show comorbidity of APD with language and reading disorders (Sharma et al., 2009) and it is supported that attention and memory might influence APD (Moore et al., 2013). It is also argued that APD could just as well be one dimension in a cluster of developmental conditions (Dawes & Bishop, 2009). Nonetheless, the profile of a child with APD should be clearly outlined in order not to be confused with other common developmental disorders (Bamiou et al., 2001).

      FM systems Personal Frequency Modulation (FM) systems are wireless listening devices that pick up the speaker's voice and transmit it to a receiver in the listener's ear. In this way, the negative effects of ambient noise, distance from speaker and reverberation are reduced (Keith & Purdy, 2014).

      Research suggests that children with APD after a prolonged use of FM systems benefit from improved speech perception which is possibly linked to an enhanced auditory system (Johnston et al., 2009). Adding to that, children with APD have shown improved speech in noise perception when using the FM system, hence emphasizing the advantages of an FM system in discriminating speech in ba
      Sponsor: University College, London
      

      Current Primary Outcome: Test of Everyday Attention for Children TEACh [ Time Frame: 6 months ]

      A validated attention test to test children's auditory attention
      
      
      

      Original Primary Outcome: Test of Everyday Attention for Children TEACh [ Time Frame: 3 months ]

      A validated attention test to test children's auditory attention
      
      
      

      Current Secondary Outcome:

      • Listening in Spatialised Noise - Sentences test (LiSN-S) [ Time Frame: 6 months ]
        Speech in noise test
      • The Children's Communication Checklist2 [ Time Frame: 6 months ]
        Parental questionnaire
      • Children's Auditory Performance Scale [ Time Frame: 6 months ]
        Parental questionnaire
      • Screening Instrument For Targeting Educational Risk Performance Scale [ Time Frame: 6 months ]
        Teacher questionnaire
      • Listening Inventory For EducationRevised [ Time Frame: 6 months ]
        Children questionnaire
      
      
      

      Original Secondary Outcome:

      • Automated Working Memory Assessment [ Time Frame: 3 months ]
        Used to examine children's memory
      • Electrophysiological measures (EEG tests will be performed on children to reveal how their brain separates different sound stimuli) [ Time Frame: 3 months ]
        These are a noninvasive way used to observe the brain responses to auditory stimuli (Dawes & Bishop, 2009). Electroencephalography (EEG) is a type of electrophysiological technique that measures brain activity from the surface of the scalp (Binnie & Prior, 1994). In this study, EEG tests will be performed on children to reveal how their brain separates different sound stimuli.
      • SCANC (Speech in noise test (the auditory figure ground of SCANC that is clinically used way used to observe the brain responses to auditory) [ Time Frame: 3 months ]
        Speech in noise test (the auditory figure ground of SCANC that is clinically used) way used to observe the brain responses to auditory stimuli (Dawes & Bishop, 2009). Electroencephalography (EEG) is a type of electrophysiological technique that measures brain activity from the surface of the scalp (Binnie & Prior, 1994). In this study, EEG tests will be performed on children to reveal how their brain separates different sound stimuli.
      • The Children's Communication Checklist2 [ Time Frame: 3 months ]
        Parental questionnaire
      • Children's Auditory Performance Scale [ Time Frame: 3 months ]
        Parental questionnaire
      • Screening Instrument For Targeting Educational Risk Performance Scale [ Time Frame: 3 months ]
        Teacher questionnaire
      • Listening Inventory For EducationRevised [ Time Frame: 3 months ]
        Children questionnaire
      
      
      Information By: University College, London
      

      Dates:
      Date Received: January 27, 2015
      Date Started: May 2016
      Date Completion:
      Last Updated: May 10, 2016
      Last Verified: May 2016