Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447285
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-19
Brief Title:
Early Objective Detection of Autism
Sponsor:
SensoDetect
Organization:
SensoDetect
Study Overview
Official Title:
Early Objective Detection of Autism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 described891314 will be used in all parts of the study in the following way
All recruited participants are to be tested using SensoDetects 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 patients 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 134852016 After the test is completed the result will be sent for analysis using SensoDetects analytical software SensoLytics The AI classification model used for analyzing traits and predicting diagnosis is Gaussian Naïve Bayes
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 described891314 will be used in all parts of the study in the following way
All recruited participants are to be tested using SensoDetects 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 patients 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 134852016 After the test is completed the result will be sent for analysis using SensoDetects analytical software SensoLytics The AI classification model used for analyzing traits and predicting diagnosis is Gaussian Naïve Bayes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None