Clinical trial NCT06734897: Impact of Music Therapy on Speech Intelligibility in Noise with Cochlear Implants
Official title: Impact of Music Therapy on Speech Intelligibility in Noise with Cochlear Implants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Music Therapy After Cochlear Implantation
Keywords: Music therapy
rehabilitation after Cochlear Implantation
Cochlear Implant
Speech Perception in Noise
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized study with a "start group A" and a "delayed group" B. Group A will begin six months of music therapy immediately after cochlear implantation, group B six months later. Another group consists of persons who do not receive any music therapy, will form the control group. The speech intelligibility values resulting from the OLSA sentence test are compared between the three groups after six and twelve months.
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to investigate whether six months of music therapy immediately after CI implantation helps to improve speech intelligibility in noise. To investigate the effect of music therapy, a randomized study will be conducted with a "start group A" and a "delayed group" B (control group 1). Group A will start six months of music therapy immediately after cochlear implantation, group B six months later. A further control group 2 will not receive any music therapy. The speech intelligibility values resulting from the OLSA sentence test will be compared between the three groups after six and twelve months.

Detailed description: Improved speech perception is a main objective for any hearing rehabilitation using hearing devices. Even more challenging is speech comprehension in noisy environments.

Music therapy is one of the approaches that can assist users with achieving better performance in situations of difficult listening comprehension such as speech perception in noisy environments. One such music therapy concept developed in Heidelberg is based on the parallelism of language and music, whereby targeted training using musical parameters such as rhythm, pitch and timbre can have an impact on the ability to perceive speech. At present, the fact that music therapy can help improve speech intelligibility is primarily based on research with normal hearing listeners.

Nowadays, cochlear implant technology has the primary goal to restore functional hearing and speech perception in people with bilateral severe-to-profound sensorineural hearing loss. Good results will be achieved by post lingually deafened CI users regarding the understanding of open-set sentences presented in quiet. But our surroundings are rarely quiet. Therefore, the goal of good rehabilitation must be to ensure that CI users also can cope well in our noisy environment. Music therapy is thus intended to be the crucial piece in the puzzle that enables such understanding in noisy situations.

This study aims to investigate the benefits of music therapy for cochlear implant users in terms of their speech intelligibility performance in noise. This is an explorative study to determine suitable parameters such as the time point of starting the music.

Eligibility criteria: Inclusion Criteria:

1. Patient aged between 18-85 years
2. Patients who undergo a new CI Implantation
3. Patients who speak German as their main language

Exclusion Criteria:

1. Patients with congenital deafness

Primary outcomes:
measure: Speech recognition threshold (SRT50) six month after Cochlear Implantation
timeFrame: six month after Cochlear Implantation
Secondary outcomes:
measure: values of SRT50 of group A and B at twelve months
timeFrame: twelve months
measure: Values of SRT50 of all groups at 12 months
timeFrame: 12 months
measure: subjective improvements of speech intelligibilty
timeFrame: 6 and 12 months
Other outcomes:
Locations:
Study officials:
References:
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