Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540677
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Musical Training in Cochlear Implant Users
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Meludia to Evaluate the Benefits of Music Training in Cochlear Implant Users a Randomized
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With this protocol we want to investigate the degree to which the use of Meludia training the online self-paced music training application can improve music perception music enjoyment and speech understanding in pediatric and postlingually deafened adult CI users The study also aims to assess the participants changes in cognitive skills attention and memory and quality of life
Participant recruitment Group A New CI users All postlingually deafened patients older than 6 years who undergo cochlear implantation at the La Paz Hospital in Madrid Spain between September 2024 and September 2027 will be invited to participate in the study
Group B Experienced CI users CI users older than 6 years old with at least 12 months of stable fitting will be recruited from the CI program at the La Paz Hospital between September 2024 and September 2027 Within this group this group it will be required that pediatric CI have been implanted before the age of 3 years
Both in the Group A and in the Group B participants at the time of enrolment will be randomly divided 11 into two groups with subjects being instructed to practice with Meludia music training application intervention group MT group and participants in the non-MT group non receiving music training NMT group
We will establish 20 minute sessions three times per week over a period of 4 weeks for participants in the MT group After this period all the participants will be evaluated session 1 An additional training period of 12 weeks also with 20-min sessions three times per week will then be conducted in the MT group followed by another evaluation session 2
The ongoing protocol for music training cannot replace conventional tools in the rehabilitation of CI users However after scientific-based improvement of music practice protocols easily implementable low-priced and with little probability of adverse effects as an auditory practice rehabilitation along with the conventional methods music training may provide an important tool for the aural rehabilitation plan
Participant recruitment Group A New CI users All postlingually deafened patients older than 6 years who undergo cochlear implantation at the La Paz Hospital in Madrid Spain between September 2024 and September 2027 will be invited to participate in the study
Group B Experienced CI users CI users older than 6 years old with at least 12 months of stable fitting will be recruited from the CI program at the La Paz Hospital between September 2024 and September 2027 Within this group this group it will be required that pediatric CI have been implanted before the age of 3 years
Both in the Group A and in the Group B participants at the time of enrolment will be randomly divided 11 into two groups with subjects being instructed to practice with Meludia music training application intervention group MT group and participants in the non-MT group non receiving music training NMT group
We will establish 20 minute sessions three times per week over a period of 4 weeks for participants in the MT group After this period all the participants will be evaluated session 1 An additional training period of 12 weeks also with 20-min sessions three times per week will then be conducted in the MT group followed by another evaluation session 2
The ongoing protocol for music training cannot replace conventional tools in the rehabilitation of CI users However after scientific-based improvement of music practice protocols easily implementable low-priced and with little probability of adverse effects as an auditory practice rehabilitation along with the conventional methods music training may provide an important tool for the aural rehabilitation plan
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None