Early, Objective Detection of Autism.

Status Not yet recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06447285
Study type	Interventional
Source	SensoDetect
Contact
Status	Not yet recruiting
Phase	N/A
Start date	May 29, 2024
Completion date	October 1, 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.