NCT06633874: SmartSpeech

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

Completed NA Last updated 15 October 2024

What this trial tests

NA trial testing TD Playing the Serious Game APSOU in Developmental Language Disorders in 520 participants. Completed in 25 November 2023.

Timeline

29 March 2021

Primary endpoint
30 June 2023

25 November 2023

Quick facts

Lead sponsor	University of Ioannina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	520
Start date	29 March 2021
Primary completion	30 June 2023
Estimated completion	25 November 2023
Sites	1 location across Greece

Drugs / interventions tested

• TD Playing the Serious Game APSOU
• Non-TD Playing Serious Game

Conditions studied

• Developmental Language Disorders — all drugs for Developmental Language Disorders →
• Developmental Articulation Disorder — all drugs for Developmental Articulation Disorder →
• Speech Disorder — all drugs for Speech Disorder →
• Neurodevelopmental Disorder (Diagnosis) — all drugs for Neurodevelopmental Disorder (Diagnosis) →

Sponsor

University of Ioannina

Who can join

Adults 4 to 12, any sex, with Developmental Language Disorders or Developmental Articulation Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Automated Detection of Neurodevelopmental Disorders Using Face-to-Face Mobile Technology Among Typically Developing Greek Children: Randomized Controlled Trial.
   Toki EI, Zakopoulou V, Tatsis G, Pange J. · · 2024 · PMID 39393054 · DOI 10.2196/53465