Early, Objective Detection of Autism.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Diagnostic test: SensoDetect BERA technology

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Phase I:

Inclusion Criteria:

- All patients attending the clinic of Autism.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Autism spectrum disorders group; All patients shall be diagnosed according to ADOS15 and DSM-517 criteria by an experienced physician. ADOS is a diagnostic tool considered the "gold standard" in ASD diagnostics.18,19 The children with confirmed diagnoses of autism will be assessed by a senior psychologist using the Stanford-Binet Intelligence Scales - Fifth edition (SB-5)21 to ensure that all ASD patients have an IQ of 70 or above. ASD patients with lower IQ will form a distinct group for specific evaluation. Using sensodetect BERA technology we will in the present study pay attention to wave I-VII amplitude as well as latencies and interpeak intervals 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.	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.
Active Comparator: totally developed group; All patients shall be diagnosed according to ADOS15 and DSM-517 criteria by an experienced physician. ADOS is a diagnostic tool considered the "gold standard" in ASD diagnostics.18,19 The children with confirmed diagnoses of autism will be assessed by a senior psychologist using the Stanford-Binet Intelligence Scales - Fifth edition (SB-5)21 to ensure that all ASD patients have an IQ of 70 or above. ASD patients with lower IQ will form a distinct group for specific evaluation. Using sensodetect BERA technology we will in the present study pay attention to wave I-VII amplitude as well as latencies and interpeak intervals 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: SensoDetect
• Collaborators: Princess Nourah Bint Abdulrahman University

Study record dates

Study Major Dates

• Study Start (Estimated): May 29, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 19, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: ABR (Auditory brainstem response)
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: HA-01-R-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No