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

NCT06534515 | Recruiting

• 1 other identifier: Young researcher study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurodevelopmental Disorders

Keywords

Tomatis; children; adolescents

Outcome Measures

Primary Outcomes (2)

• Air conduction thresholds

  % Spatialization errors in air conduction

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

• Bone conduction thresholds

  % Spatialization errors in Bone conduction

  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

  Change from baseline DD_CGAS (time 0) at immediately after the intervention (time 1)

Study Arms (2)

Intervention/Treatment

EXPERIMENTAL

Tomatis Auditory stimulation.

Device: Tomatis auditory stimulation

No intervention

NO INTERVENTION

Waitlist control.

Interventions

Tomatis auditory stimulation DEVICE

Traditional Tomatis Method Protocol

Intervention/Treatment

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- neurodevelopmental disorder

You may not qualify if:

• intellectual disability

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Andeea Robe

Floreşti, Cluj, 407280, Romania

RECRUITING

Related Publications (2)

• Gerritsen, J. (2009). A Review of Research Done on Tomatis Auditory Stimulation.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Andreea Robe

  UBB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreea Ms Robe, PhD, M.D

CONTACT

0752668688; andreearobe@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: December 1, 2023
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)