Smart Computing Models, Sensors, and Early Diagnostic Speech and Language Deficiencies Indicators in Child Communication

NCT06633874 | Completed DMC

• 2 other identifiers: HP1AB-28185 (MIS: 5033088)18435/15.05.2020
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

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 speech/language 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. 1.Do differences exist between typically developing and neurodevelopmentally atypical children when engaging with the serious game used in the study?
2. 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?

Conditions

Developmental Language Disorders; Developmental Articulation Disorder; Speech Disorder; Neurodevelopmental Disorder (Diagnosis)

Keywords

screening; developmental speech and language disorders; speech disorder; language disorder; developmental disorder; developmental deficiencies; neurodevelopmental disorder; Early Diagnostic Speech and Language Deficiencies Indicators; Machine Learning; Neural Networks; Serious Game; Child Communication; neurodevelopmental screening

Outcome Measures

Primary Outcomes (16)

• Speech and language for TD children

  Score on Serious Game responses in Speech and language activities (0 - 100) by TD children

  10-20 minutes

• Psychomotor for TD children

  Score on Serious Game responses in Psychomotor activities (0 - 100) by TD children

  10-20 minutes

• Cognitive for TD children

  Score on Serious Game responses in Cognitive activities (0 - 100) by TD children

  10-20 minutes

• Psychoemotional for TD children

  Score on Serious Game responses in Psychoemotional activities (0 - 100) by TD children

  10-20 minutes

• Hearing for TD children

  Score on Serious Game responses in Hearing activities (0 - 100) by TD children

  10-20 minutes

• Eye-tracking fixation duration for TD children

  Fixation Duration is the time the gaze stays on a single point in milliseconds (during specific activities in the Serious Game)

  1-10 minutes

• Eye-tracking trajectory path for TD children

  Trajectory Path is the overall movement path of the gaze in millimeters on screen (during specific activities in the Serious Game)

  1-10 minutes

• Heart rate variability for TD children

  Heart rate variability during the game that is calculated by HRV=(HRe-HRs)/HRs, HRs: Heart Rate at the start of the measurement, HRe: Heart Rate at the end of the measurement. The duration between start - end of each activity measurement is a few seconds

  1-10 minutes

• Speech and language for non-TD children

  Score on Serious Game responses in Speech and language activities (0 - 100) by non-TD children

  10-20 minutes

• Psychomotor for non-TD children

  Score on Serious Game responses in Psychomotor activities (0 - 100) by non-TD children

  10-20 minutes

• Cognitive for non-TD children

  Score on Serious Game responses in Cognitive activities (0 - 100) by non-TD children

  10-20 minutes

• Psychoemotional for non-TD children

  Score on Serious Game responses in Psychoemotional activities (0 - 100) by non-TD children

  10-20 minutes

• Hearing for non-TD children

  Score on Serious Game responses in Hearing activities (0 - 100) by non-TD children

  10-20 minutes

• Eye-tracking fixation duration for non-TD children

  Fixation Duration is the time the gaze stays on a single point in milliseconds (during specific activities in the Serious Game)

  1-10 minutes

• Eye-tracking trajectory path for non-TD children

  Trajectory Path is the overall movement path of the gaze in millimeters on screen (during specific activities in the Serious Game)

  1-10 minutes

• Heart rate variability for non-TD children

  Heart rate variability during the game that is calculated by HRV=(HRe-HRs)/HRs, HRs: Heart Rate at the start of the measurement, HRe: Heart Rate at the end of the measurement. The duration between start - end of each activity measurement is a few seconds

  1-10 minutes

Study Arms (2)

Typically Developed Children PLAYING SERIOUS GAME

EXPERIMENTAL

The arm describes the data collection process to design an intelligent system that contributes to implementing new innovative tools to assist clinicians and/or other professionals in the complicated screening and diagnostic procedures for communication deficiencies in children. The main objective of this arm is to feed data from collected responses of TD children to the backend of the SmartSpeech system. The data we collect are Game responses, Speech responses, Gaze data from the tablet camera, and Heart Rate Variability (captured through the smartwatch). The backend system will use the data for training, evaluating, and validating the intelligence system.

Diagnostic Test: TD Playing the Serious Game APSOU

Non-Typically Developed Children PLAYING SERIOUS GAME

ACTIVE COMPARATOR

The arm describes the data collection process to design an intelligent system that contributes to implementing new innovative tools to assist clinicians and/or other professionals in the complicated screening and diagnostic procedures for communication deficiencies in children. The main objective of this arm is to feed data from collected responses of Non-TD children to the backend of the SmartSpeech system. The data we collect are Game responses, Speech responses, Gaze data from the tablet camera, and Heart Rate Variability (captured through the smartwatch). The backend system will use the data for training, evaluating, and validating the intelligence system.

Diagnostic Test: Non-TD Playing Serious Game

Interventions

TD Playing the Serious Game APSOU DIAGNOSTIC_TEST

After parents participate in informative meetings, they proceed with written consent, SmartSpeech enrollment, and child developmental history. Then, the child may interact with the Serious Game. Typically developed (TD) children engage under the clinician's face-to-face supervision with the serious game APSOU, which assesses developmental domains, including speech, language, psychomotor, cognitive, psychoemotional, and hearing abilities. The average time for TD children to play the whole game is estimated to be 45 minutes.

Typically Developed Children PLAYING SERIOUS GAME

Non-TD Playing Serious Game DIAGNOSTIC_TEST

After parents participate in informative meetings, they proceed with written consent, SmartSpeech enrollment, and child developmental history. Then the child may interact with the serious game. Non-typically developed (non-TD) children engage under the clinician's face-to-face supervision with the serious game Apsou, which assesses developmental domains, including speech, language, psychomotor, cognitive, psychoemotional, and hearing abilities. The average time for non-TD children to play the whole game is estimated to be over an hour.

Non-Typically Developed Children PLAYING SERIOUS GAME

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Typically developing preschoolers and school-aged children
• Children diagnosed with neurodevelopmental disorders
• Children should be native Greek speakers

You may not qualify if:

• Children with other medical conditions
• Children on medications that might affect the results of the study

Sponsors & Collaborators

• University of Ioannina: lead
• DOTSOFT SA - GR: collaborator
• TELEGLOBAL LP - GR: collaborator
• Region of Epirus (Regional Operational Programme 'Epirus 2014-2020') - GR: collaborator
• University Hospital, Ioannina: collaborator

Study Sites (1)

University of Ioannina

Ioannina, 45500, Greece

Location

Related Publications (1)

• Toki EI, Zakopoulou V, Tatsis G, Pange J. Automated Detection of Neurodevelopmental Disorders Using Face-to-Face Mobile Technology Among Typically Developing Greek Children: Randomized Controlled Trial. JMIR Form Res. 2024 Oct 11;8:e53465. doi: 10.2196/53465.

  PMID: 39393054 DERIVED

MeSH Terms

Conditions

Language Development Disorders; Articulation Disorders; Speech Disorders; Neurodevelopmental Disorders; Disease; Language Disorders; Developmental Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathologic Processes

Study Officials

• Eugenia I Toki, PhD

  University of Ioannina, Greece

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, SmartSpeech Scientific Project Manager

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 9, 2024
• Study Start: March 29, 2021
• Primary Completion: June 30, 2023
• Study Completion: November 25, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)