Early, Objective Detection of Autism.

Autism Spectrum Disorder Clinical Trial

Official title:

Early, Objective Detection of Autism.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447285
• Other study ID #: HA-01-R-104
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 29, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: June 2024
• Source: SensoDetect
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1- To test the hypothesis that using the SensoDetect Brainstem Evoked Response Audiometry (BERA) technology may be an effective support tool for pediatricians to detect autism.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

Phase I:

Inclusion Criteria:

• All patients attending the clinic of Autism.

Exclusion Criteria:

• Hearing impairment

• Down syndrome

• Cerebral Palsy

• Significant brain damage Intellectual disability.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Diagnostic Test:
• SensoDetect BERA technology
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SensoDetect	Princess Nourah Bint Abdulrahman University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wave I-VII amplitude	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.	phase 1 of this study one year
Primary	Wave I-VII latencies	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.	phase 1 of this study one year
Primary	Wave I-VII interpeak intervals	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.	phase 1 of this study one year