Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540989
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Noise-augmented Automatic Speech Recognition for Speech Treatment in Parkinsons Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Understand Me for Life Using Noise-augmented Automatic Speech Recognition to Improve Intelligibility in Parkinsons Disease
Status:
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:
The goal of this clinical trial is to learn whether noise-augmented feedback using automatic speech recognition improves intelligibility and social participation in individuals with Parkinsons disease The main questions the investigators will address are
Does noise-augmented feedback lead to increased intelligibility as measured by transcription accuracy scores
Does a self-managed speech protocol lead to increased social participation as measured by the Communicative Participation Item Bank and the Communicative Effectiveness Index questionnaires
Participants will
Receive 2-4 initial speech assessments in-person in our lab Engage in speech treatment sessions at home using their phone and computer four days a week for four weeks Four of those sessions will be directly monitored online by a speech-language pathologist The rest of the sessions are completed by the participant
Come to the lab for two post-treatment assessments following completion of treatment
Come to the lab six months after treatment completion for an additional assessment
Does noise-augmented feedback lead to increased intelligibility as measured by transcription accuracy scores
Does a self-managed speech protocol lead to increased social participation as measured by the Communicative Participation Item Bank and the Communicative Effectiveness Index questionnaires
Participants will
Receive 2-4 initial speech assessments in-person in our lab Engage in speech treatment sessions at home using their phone and computer four days a week for four weeks Four of those sessions will be directly monitored online by a speech-language pathologist The rest of the sessions are completed by the participant
Come to the lab for two post-treatment assessments following completion of treatment
Come to the lab six months after treatment completion for an additional assessment
Detailed Description:
The goal of this clinical trial is to learn whether noise-augmented feedback using automatic speech recognition improves intelligibility and social participation in individuals with Parkinsons disease
Data collection will be face-to-face at a convenient time for participants The screening and assessment sessions will take place in the Communication Technology and Language Diversity Lab Room 952a on the 9th floor of the 528 Building at Teachers College Columbia University 525W 120th St New York NY 10027
Treatment sessions will be conducted independently by the participant in the participants home Four out of the 16 treatment sessions will be supervised online via Zoom by a licensed speech and language pathologist
The study involves 5-7 assessment sessions including one 6-month follow-up and 16 treatment sessions 1 month Each participant is expected to be involved in the study for 7-8 months
Participants will first attend a screening session to confirm eligibility which will involve a hearing screening a brief cognitive screening and a brief depression screening If the screening is successful participants will complete two or four assessment sessions before initiation of the treatment protocol the number of assessment sessions depends on their group allocation immediate treatment or deferreddelayed treatment
Screenings will only be completed once during their first in person visit on the Teachers College campus
In the first assessment session participants will be asked to complete voice recordings and three questionnaires Participants will complete the same speech tasks and questionnaires in the rest of the assessment sessions The number of assessment sessions 5 versus 7 depends on whether they are assigned to the immediate treatment group or the delayed treatment group Group assignments are random and participants will always receive the treatment protocol
Each assessment session is estimated to take 60-90 minutes to complete
Participants will complete the treatment sessions on their own using your phone and computer Participants will be instructed to find a quiet place at home and practice their exercises at a time when they feel ok and not too tired They will log in onto our web-based app Understand Me for Life to start their speech session App instructions will be provided during the second assessment session for familiarization purposes
Each session will contain 20 short sentences between 3 and 7 words in length Participants will be asked to try to complete 5 sessions in 1 hour a total of 100 sentences taking as many breaks as they may need Participants will be instructed to complete 1-hour of speech exercises 4 days a week for 4 weeks The total number of days to participate in the treatment study is 16
Data collection will be face-to-face at a convenient time for participants The screening and assessment sessions will take place in the Communication Technology and Language Diversity Lab Room 952a on the 9th floor of the 528 Building at Teachers College Columbia University 525W 120th St New York NY 10027
Treatment sessions will be conducted independently by the participant in the participants home Four out of the 16 treatment sessions will be supervised online via Zoom by a licensed speech and language pathologist
The study involves 5-7 assessment sessions including one 6-month follow-up and 16 treatment sessions 1 month Each participant is expected to be involved in the study for 7-8 months
Participants will first attend a screening session to confirm eligibility which will involve a hearing screening a brief cognitive screening and a brief depression screening If the screening is successful participants will complete two or four assessment sessions before initiation of the treatment protocol the number of assessment sessions depends on their group allocation immediate treatment or deferreddelayed treatment
Screenings will only be completed once during their first in person visit on the Teachers College campus
In the first assessment session participants will be asked to complete voice recordings and three questionnaires Participants will complete the same speech tasks and questionnaires in the rest of the assessment sessions The number of assessment sessions 5 versus 7 depends on whether they are assigned to the immediate treatment group or the delayed treatment group Group assignments are random and participants will always receive the treatment protocol
Each assessment session is estimated to take 60-90 minutes to complete
Participants will complete the treatment sessions on their own using your phone and computer Participants will be instructed to find a quiet place at home and practice their exercises at a time when they feel ok and not too tired They will log in onto our web-based app Understand Me for Life to start their speech session App instructions will be provided during the second assessment session for familiarization purposes
Each session will contain 20 short sentences between 3 and 7 words in length Participants will be asked to try to complete 5 sessions in 1 hour a total of 100 sentences taking as many breaks as they may need Participants will be instructed to complete 1-hour of speech exercises 4 days a week for 4 weeks The total number of days to participate in the treatment study is 16
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