Early, Objective Detection of Autism. | Clinical Trial

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study will be conducted through two phases:

Phase I: A case-control study.

This will be done at Princess Noura University/ King Abdullah Abdulaziz University Hospital, Riyadh, Kingdom of Saudi Arabia from January 2024 to January 2027.

The SensoDetect BERA technology previously described8,9,13,14 will be used in all parts of the study in the following way:

All recruited participants are to be tested using SensoDetect's patented technology. All tests shall be performed in a quiet and darkened room. Participants will be asked to comfortably sit in an armchair in a resting position (part 1 only). Surface electrodes will then be attached to the skin over the mastoid bones behind the left and right ear, with a ground electrode on one arm. Two reference electrodes will also be placed on the forehead. Before each test session, the procedure shall be fully explained to the test subject or parents.

The subjects will then be instructed to relax with their eyes closed and are permitted to fall asleep (with modifications in part 3). The test will require no active participation other than sound stimulation. The subjects will be tested one at a time, and the duration of the testing procedure will be 15 min.

The method is based on an electrophysiological test battery that emits 1024 click sounds divided into 4 sessions for 14 minutes. The data analysis software uses advanced mathematical algorithms and Artificial intelligence (AI) to analyze and distinguish the patient's markers and compare them with diagnostic and non-diagnostic groups. BERA is CE and MDD (MDD stands for Medical Device Directive and is an approval for the device to be used under European law) approved. SensoDetect holds the ISO standard under medical technical products 13485:2016. After the test is completed, the result will be sent for analysis using SensoDetect's analytical software (SensoLytics). The AI classification model used for analyzing traits and predicting diagnosis is Gaussian Naïve Bayes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Phase I:

Inclusion criteria

All patients attending the clinic of Autism.

Exclusion criteria

Hearing impairment
Down syndrome
Cerebral Palsy
Significant brain damage Intellectual disability.

Treatment and study plan

SensoDetect BERA technology

Diagnostic Test

All recruited participants are to be tested using SensoDetect's patented technology. All tests shall be performed in a quiet and darkened room. Participants will be asked to be comfortably seated in an armchair in a resting position (part 1 only). Surface electrodes will then be attached to the skin over the mastoid bones behind the left and right ear, with a ground electrode on one arm. Two reference electrodes will also be placed on the forehead. Before each test session, the procedure shall be fully explained to the test subject or parents.

The subjects will then be instructed to relax with their eyes closed and are permitted to fall asleep (with modifications in part 3). The test will require no active participation other than being subjected to sound stimulation. The subjects will be tested one at a time, and the duration of the testing procedure will be 15 min.

Primary outcomes

wave I-VII amplitude

Time frame: phase 1 of this study one year

Wave I-VII amplitude allow comparison of both groups. Group differences between autistic and totally developed (TD) groups will be tested intra-individually and between groups and presented.
Wave I-VII latencies

Time frame: phase 1 of this study one year

wave I-VII latencies to broaden the perspective and allow a better comparison of both groups.

Group differences between autistic and TD groups will be tested intra-individually and between groups and presented.
Wave I-VII interpeak intervals

Time frame: phase 1 of this study one year

Wave I-VII interpeak intervals allow a comparison of both groups. Group differences between autistic and TD groups will be tested intra-individually and between groups and presented.

Sponsors and collaborators

Lead sponsor

SensoDetect

Industry

Collaborators

Princess Nourah Bint Abdulrahman University

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Jun 7, 2024
Registry last updated: Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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