Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633874
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Smart Computing Models Sensors and Early Diagnostic Speech and Language Deficiencies Indicators in Child Communication
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Smart Computing Models Sensors and Early Diagnostic Speech and Language Deficiencies Indicators in Child Communication
Status:
COMPLETED
Status Verified Date:
2024-10
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:
SmartSpeech
Brief Summary:
This clinical trial aims to justify a protocol for designing and developing an automated decision-making system to support and enhance screening and early detection procedures for developmental speechlanguage difficulties in child communication The system will utilize smart computing models sensors and early diagnostic speech and language deficiency indicators The study participants will be typically and non-typically neurodevelopmentally atypical developing children primarily in preschool and elementary school
The key research questions the study seeks to address are
1 Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study
2 If such differences are identified can the collected data be utilized to train an automated decision-making system capable of accurately distinguishing between typically and neurodevelopmentally atypical children based on speech and language deficiencies
Researchers will compare typically and non-typically developed children to see if the system can incorporate multiple data points from assessment domains to create a diagnostic profile
After the parents are informed of the study and provide written consent they enroll in the system Participants will be asked to wear a smartwatch and play a serious game on a tablet under the supervision of a clinician The system will collect data from the gameplay and sensors
The key research questions the study seeks to address are
1 Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study
2 If such differences are identified can the collected data be utilized to train an automated decision-making system capable of accurately distinguishing between typically and neurodevelopmentally atypical children based on speech and language deficiencies
Researchers will compare typically and non-typically developed children to see if the system can incorporate multiple data points from assessment domains to create a diagnostic profile
After the parents are informed of the study and provide written consent they enroll in the system Participants will be asked to wear a smartwatch and play a serious game on a tablet under the supervision of a clinician The system will collect data from the gameplay and sensors
Detailed Description:
In recent years integrating digital and mobile technologies in health and education has opened new possibilities for monitoring and assessment This study will build on these advancements by implementing artificial intelligence AI and machine learning models that offer real-time decision-making and personalized feedback By automating critical aspects of the diagnostic process this system will help bridge the gap between traditional clinical expertise and cutting-edge technology ultimately enhancing early intervention efforts
The SmartSpeech study will be a clinical trial designed to create and validate an automated decision-making system to enhance the screening and early detection of developmental speech and language difficulties in young children This study will target typically and non-typically neurodevelopmentally atypical developing children primarily focusing on preschool and elementary school-aged participants The system will employ intelligent computing models biometric sensors and early diagnostic indicators of speech and language deficiencies to provide clinicians with a robust tool for identifying potential developmental issues
Two primary research questions drive the trial
1 Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study
2 If such differences are identified can the collected data be utilized to train an automated decision-making system that accurately distinguishes between typically and neurodevelopmentally atypical children based on speech and language deficiencies
To assess speech and language developmental skills and their manifestations the interdisciplinary team will design a serious game SG based on theories that measure speech and language and psychomotor cognitive psychoemotional and hearing skills Each domain will assess the performance of specific tasks within the SG activities for the participant
To address the questions of this study data from typically developing children will be compared with data from non-typically developing children analyzing whether the AI system can synthesize multiple data points across assessment domains to generate a comprehensive diagnostic profile
Participants will be recruited through an open call distributed via private and public health and educational establishments across Greece The recruitment process will focus on parents of typically and non-typically developing children aged 4 to 12 Parents will be invited to attend informational meetings where the objectives procedures and ethical guidelines of the study will be thoroughly explained
During these sessions parents will receive comprehensive information about the purpose of the study including the specific role of the serious game developed in the study The nature of the game the expected involvement of their children and the data collection methods will be discussed in detail to ensure transparency Parents will be asked to provide informed written consent for their children to participate in full compliance with the General Data Protection Regulation and ethical considerations These steps are essential to ensure that the rights and privacy of the participants will be protected throughout the study Parents will also provide their childs developmental history in an online questionnaire embedded in the system
The study will include typically developing preschool and school-aged children and non-typically developing children It will not include children with other medical conditions or on medications that could potentially influence the results
After an informative meeting and written consent from parents participants will wear a smartwatch and engage in a serious game designed and developed by the research team Children will play the SG under the direct supervision of clinicians This game will be designed to assess various developmental domains including speech language psychomotor skills cognitive function psychoemotional behavior and hearing abilities The game will capture speech and language data through gameplay interactions alongside sensor data from the wearable device and the tablet camera eye tracking and heart rate variability
This game-based approach will naturally and engagingly collect diverse data points ensuring a comprehensive evaluation of the childamp39s speech and language abilities
The system will form its datasets for analysis to detect speech and language development feeding data into the selected artificial intelligence algorithms The study will measure communication psychomotor cognitive and psychoemotional skills through designed activities The responses during gameplay will be evaluated creating the developmental profile of the participant
This structured and ethical recruitment process will ensure complete adherence to data protection and ethical standards while maintaining active engagement from both parents and children By incorporating face-to-face supervision and real-time monitoring during gameplay the study will guarantee the quality and integrity of the data collected for analysis
The SG paired with sensors from the smartwatch will collect real-time data including
Game responses
Speech responses
Gaze data from the tablet camera
Heart Rate Variability captured through the smartwatch
This multi-modal data will be processed using neural networkmachine learning algorithms to classify speech and language abilities across different developmental stages The use of these advanced AI models will enable the system to
Identify patterns of speechlanguage deficiencies
Differentiate between typically and non-typically developed children
Create individualized diagnostic profiles for each participant
Finally an evaluation and verification of the intelligent system will be performed
The SmartSpeech study will be a clinical trial designed to create and validate an automated decision-making system to enhance the screening and early detection of developmental speech and language difficulties in young children This study will target typically and non-typically neurodevelopmentally atypical developing children primarily focusing on preschool and elementary school-aged participants The system will employ intelligent computing models biometric sensors and early diagnostic indicators of speech and language deficiencies to provide clinicians with a robust tool for identifying potential developmental issues
Two primary research questions drive the trial
1 Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study
2 If such differences are identified can the collected data be utilized to train an automated decision-making system that accurately distinguishes between typically and neurodevelopmentally atypical children based on speech and language deficiencies
To assess speech and language developmental skills and their manifestations the interdisciplinary team will design a serious game SG based on theories that measure speech and language and psychomotor cognitive psychoemotional and hearing skills Each domain will assess the performance of specific tasks within the SG activities for the participant
To address the questions of this study data from typically developing children will be compared with data from non-typically developing children analyzing whether the AI system can synthesize multiple data points across assessment domains to generate a comprehensive diagnostic profile
Participants will be recruited through an open call distributed via private and public health and educational establishments across Greece The recruitment process will focus on parents of typically and non-typically developing children aged 4 to 12 Parents will be invited to attend informational meetings where the objectives procedures and ethical guidelines of the study will be thoroughly explained
During these sessions parents will receive comprehensive information about the purpose of the study including the specific role of the serious game developed in the study The nature of the game the expected involvement of their children and the data collection methods will be discussed in detail to ensure transparency Parents will be asked to provide informed written consent for their children to participate in full compliance with the General Data Protection Regulation and ethical considerations These steps are essential to ensure that the rights and privacy of the participants will be protected throughout the study Parents will also provide their childs developmental history in an online questionnaire embedded in the system
The study will include typically developing preschool and school-aged children and non-typically developing children It will not include children with other medical conditions or on medications that could potentially influence the results
After an informative meeting and written consent from parents participants will wear a smartwatch and engage in a serious game designed and developed by the research team Children will play the SG under the direct supervision of clinicians This game will be designed to assess various developmental domains including speech language psychomotor skills cognitive function psychoemotional behavior and hearing abilities The game will capture speech and language data through gameplay interactions alongside sensor data from the wearable device and the tablet camera eye tracking and heart rate variability
This game-based approach will naturally and engagingly collect diverse data points ensuring a comprehensive evaluation of the childamp39s speech and language abilities
The system will form its datasets for analysis to detect speech and language development feeding data into the selected artificial intelligence algorithms The study will measure communication psychomotor cognitive and psychoemotional skills through designed activities The responses during gameplay will be evaluated creating the developmental profile of the participant
This structured and ethical recruitment process will ensure complete adherence to data protection and ethical standards while maintaining active engagement from both parents and children By incorporating face-to-face supervision and real-time monitoring during gameplay the study will guarantee the quality and integrity of the data collected for analysis
The SG paired with sensors from the smartwatch will collect real-time data including
Game responses
Speech responses
Gaze data from the tablet camera
Heart Rate Variability captured through the smartwatch
This multi-modal data will be processed using neural networkmachine learning algorithms to classify speech and language abilities across different developmental stages The use of these advanced AI models will enable the system to
Identify patterns of speechlanguage deficiencies
Differentiate between typically and non-typically developed children
Create individualized diagnostic profiles for each participant
Finally an evaluation and verification of the intelligent system will be performed
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