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NCT Number: NCT06534515

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

The current study aims to explore the preliminary efficacy of the Tomatis method on auditory processing in children with NDDs.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andeea Robe

Floreşti, Cluj, 407280, Romania

Location status: Recruiting

Location contact

Andreea Ms Robe, M.D.

CONTACT

[email protected]

0752668688

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • neurodevelopmental disorder

Exclusion criteria

  • intellectual disability

Treatment and study plan

Tomatis auditory stimulation

Device

Traditional Tomatis Method Protocol

Primary outcomes

  1. Air conduction thresholds

    Time frame: Change from baseline AC (time 0) at immediately after the intervention (time 1)

    % Spatialization errors in air conduction

  2. Bone conduction thresholds

    Time frame: Change from baseline BC(time 0) at immediately after the intervention (time 1)

    % Spatialization errors in Bone conduction

Secondary outcomes

  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)

    Developmental Disability Children's Global Assesment Scale total score(highest score 100; superior functioning; lowest score 1: extreme impairment)

Study contacts

Contact information is provided by the study sponsor or research team.

Andreea Ms Robe, PhD, M.D

CONTACT

[email protected]

0752668688 ext. +40

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

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

Acronym: TomatisOn

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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