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

August 7, 2024 updated by: Andeea Robe, Babes-Bolyai University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
    • Cluj
      • Floresti, Cluj, Romania, 407280
        • Recruiting
        • Andeea Robe
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- neurodevelopmental disorder

Exclusion Criteria:

  • intellectual disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention/Treatment
Tomatis Auditory stimulation.
Device: Tomatis auditory stimulation
Traditional Tomatis Method Protocol
No Intervention: No intervention
Waitlist control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Air conduction thresholds
Time Frame: Change from baseline AC (time 0) at immediately after the intervention (time 1)
% Spatialization errors in air conduction
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)
% Spatialization errors in Bone conduction
Change from baseline BC(time 0) at immediately after the intervention (time 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline DD_CGAS (time 0) at immediately after the intervention (time 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Babes-Bolyai University

Investigators

  • Principal Investigator: Andreea Robe, UBB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Young researcher study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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