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Recruiting NCT06534515

The Effect of Tomatis Auditory Stimulation in Children and Adolescents With NDDs

No phase Interventional Neurodevelopmental Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tomatis auditory stimulation.
Who it may be relevant to
Registry conditions: Neurodevelopmental Disorders. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Tomatis Auditory Stimulation in Children and Adolescent With Neurodevelopmental Disorders (TomatisOn)

Overview

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).

Interventions

  • Device Tomatis auditory stimulation
    Traditional Tomatis Method Protocol

Primary outcome measures

  • Air conduction thresholds [Time frame: Change from baseline AC (time 0) at immediately after the intervention (time 1)]
  • Bone conduction thresholds [Time frame: Change from baseline BC(time 0) at immediately after the intervention (time 1)]
Secondary outcome measures (1)
  • 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)]

Eligibility criteria

Inclusion criteria

\- neurodevelopmental disorder

Exclusion criteria

  • intellectual disability

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Romania · 1 center
  • Andeea Robe — Floreşti

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

Identifiers

NCT: NCT06534515 · Young researcher study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗