Neurodevelopmental DisordersTomatisOnNCT06534515
The Effect of Tomatis Auditory Stimulation in Children and Adolescents With NDDs
A study testing Tomatis auditory stimulation in people with Neurodevelopmental Disorders, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
The current study aims to explore the preliminary efficacy of the Tomatis method on auditory processing in children with NDDs. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- Tomatis auditory stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRomania
- Study dates
- 1 Dec 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- neurodevelopmental disorder
Who cannot join
- intellectual disability
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Andeea Robe
Floreşti, Cluj, 407280
Andreea Ms Robe, M.D., 0752668688, andreearobe@yahoo.com
About this study
Official title: The Effect of Tomatis Auditory Stimulation in Children and Adolescent With Neurodevelopmental Disorders (TomatisOn)
The current study aims to explore the preliminary efficacy of the Tomatis method on auditory processing in children with NDDs.
Read the detailed description
This will be a two-arm, randomized controlled trial exploring whether the Tomatis training could improve the components of auditory processing in children with Neurodevelopmental Disorders referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline (T1), immediately after the training (T2).
- Conditions
- Neurodevelopmental Disorders
- Being tested
- Tomatis auditory stimulation
- Keywords
- Tomatis, children, adolescents
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomatis auditory stimulationDevice
Traditional Tomatis Method Protocol
| Study group | Role | What they receive |
|---|---|---|
| Intervention/Treatment | Experimental | Tomatis Auditory stimulation. Receives: Device: Tomatis auditory stimulation |
| No intervention | No intervention | Waitlist control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air conduction thresholds
% Spatialization errors in air conduction
Measured: Change from baseline AC (time 0) at immediately after the intervention (time 1)
Bone conduction thresholds
% Spatialization errors in Bone conduction
Measured: Change from baseline BC(time 0) at immediately after the intervention (time 1)
Secondary outcomes (1)
Developmental Disability Children's Global Assesment Scale total score
Developmental Disability Children's Global Assesment Scale total score(highest score 100; superior functioning; lowest score 1: extreme impairment)
Measured: Change from baseline DD_CGAS (time 0) at immediately after the intervention (time 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Dec 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a two-arm, randomized controlled trial exploring whether the Tomatis training could improve the components of auditory processing in children with NDDs referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline (T1), immediately after the training (T2).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andeea Robe, Babes-Bolyai University
- Investigators
- Andreea Robe, Principal investigator, UBB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534515
- Sponsor's protocol ID
- Young researcher study
- Acronym
- TomatisOn
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerritsen, J. (2009). A Review of Research Done on Tomatis Auditory Stimulation.
Gilmor, T. (1999). The Efficacy of the Tomatis Method for Children with Learning and Communication Disorders: A Meta-Analysis. International Journal of Listening, 13(1), 12-23. https://doi.org/10.1080/10904018.1999.10499024
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tomatis Auditory Stimulation in Children and Adolescent With Neurodevelopmental Disorders (TomatisOn)
- ClinicalTrials.gov ID
- NCT06534515
- Acronym / sponsor ID
- TomatisOn / Young researcher study
- Conditions
- Neurodevelopmental Disorders
- Keywords
- Tomatis, children, adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 2 Aug 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.
The current study aims to explore the preliminary efficacy of the Tomatis method on auditory processing in children with NDDs.
Detailed description
This will be a two-arm, randomized controlled trial exploring whether the Tomatis training could improve the components of auditory processing in children with Neurodevelopmental Disorders referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline (T1), immediately after the training (T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a two-arm, randomized controlled trial exploring whether the Tomatis training could improve the components of auditory processing in children with NDDs referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline (T1), immediately after the training (T2).
| Arm | Type | Receives |
|---|---|---|
| Intervention/Treatment | Experimental | Device: Tomatis auditory stimulationTomatis Auditory stimulation. |
| No intervention | No intervention | –Waitlist control. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- neurodevelopmental disorder
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Tomatis auditory stimulationTraditional Tomatis Method Protocol | Device | Intervention/Treatment |
Primary outcome
Air conduction thresholds
Time frame: Change from baseline AC (time 0) at immediately after the intervention (time 1)
% Spatialization errors in air conduction
Bone conduction thresholds
Time frame: Change from baseline BC(time 0) at immediately after the intervention (time 1)
% Spatialization errors in Bone conduction
1 secondary outcome
Developmental Disability Children's Global Assesment Scale total score
Time frame: Change from baseline DD_CGAS (time 0) at immediately after the intervention (time 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- BackgroundGerritsen, J. (2009). A Review of Research Done on Tomatis Auditory Stimulation.
- BackgroundGilmor, T. (1999). The Efficacy of the Tomatis Method for Children with Learning and Communication Disorders: A Meta-Analysis. International Journal of Listening, 13(1), 12-23. https://doi.org/10.1080/10904018.1999.10499024
- 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. This study is not recruiting at the moment.
Andreea Robe principal investigator
UBB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tomatis auditory stimulation in people with Neurodevelopmental Disorders, run by Babes-Bolyai University at 1 site in Romania.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreea Ms Robe, PhD, M.D (0752668688 ext. +40, andreearobe@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Air conduction thresholds (time frame: Change from baseline AC (time 0) at immediately after the intervention (time 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06534515, which also lists 2 linked publications.
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 9 Aug 2024.