Autism Spectrum DisorderNCT06447285
Early, Objective Detection of Autism.
A study testing SensoDetect BERA technology in people with Autism Spectrum Disorder, run by SensoDetect.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- SensoDetect BERA technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All patients attending the clinic of Autism.
Who cannot join
- Hearing impairment
- Down syndrome
- Cerebral Palsy
- Significant brain damage Intellectual disability.
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- SensoDetect BERA technology
- Keywords
- ABR (Auditory brainstem response)
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SensoDetect BERA technologyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Autism spectrum disorders group | Active comparator | 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. Receives: Diagnostic Test: SensoDetect BERA technology |
| totally developed group | Active comparator | 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. Receives: Diagnostic Test: SensoDetect BERA technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: phase 1 of this study one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start29 May 2024 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SensoDetect
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447285
- Sponsor's protocol ID
- HA-01-R-104
- Status last verified
- Jun 2024
- First submitted
- 19 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early, Objective Detection of Autism.
- ClinicalTrials.gov ID
- NCT06447285
- Acronym / sponsor ID
- HA-01-R-104
- Conditions
- Autism Spectrum Disorder
- Keywords
- ABR (Auditory brainstem response)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- SensoDetectIndustry (pharma, biotech, devices)
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Study start
- 29 May 2024 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism spectrum disorders group | Active comparator | Diagnostic Test: SensoDetect BERA technologyAll 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. |
| totally developed group | Active comparator | Diagnostic Test: SensoDetect BERA technologyAll 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients attending the clinic of Autism.
Key exclusion criteria (4 listed)
- Hearing impairment
- Down syndrome
- Cerebral Palsy
- Significant brain damage Intellectual disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SensoDetect BERA technologyAll 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. | Diagnostic test | Autism spectrum disorders group, totally developed group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SensoDetect BERA technology in people with Autism Spectrum Disorder, run by SensoDetect.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wave I-VII amplitude (time frame: phase 1 of this study one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.