Actively Recruiting

Phase Not Applicable
Age: 9Years - 18Years
All Genders
Healthy Volunteers
ID03425669

Acoustic and Vestibular Noise as Possible Non-pharmacological Treatments of ADHD in School Children

Led by Lund University · Updated on 2023-10-11

70

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of acoustic and vestibular noise as possible non-medication treatments for children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). The study builds on previous findings that auditory noise can improve cognitive performance in inattentive children, including those diagnosed with ADHD, sometimes matching or exceeding the benefits of medication. It also explores vestibular stimulation's potential to enhance brain activity related to spatial orientation and learning. The study is conducted by Lund University and involves both children diagnosed with ADHD and typically developing controls. Participants will be divided into groups receiving different interventions: active medication, active vestibular noise stimulation, placebo medication with sham stimulation, or sham stimulation alone. The ADHD group will undergo testing on three separate occasions spaced 2-3 weeks apart, each involving different combinations of medication and stimulation in a double-blind, randomized crossover design. Control children will be tested twice under active or sham stimulation without medication. The study also includes an evaluation of an iPhone auditory noise application to assess its benefit in a typical school setting. During the study, participants will complete various cognitive and motor tests including episodic memory (Auditory Verbal Learning Test), visuo-spatial working memory (Spanboard task), motor-neurological assessments, and finger tapping tasks. The iPhone application will be assessed by students, teachers, and parents over about five months. Researchers will measure performance changes related to these interventions, monitor safety, and gather feedback on the app's use in everyday school environments.

CONDITIONS

Brief Title

Acoustic and Vestibular Noise as Possible Non-pharmacological Treatment of ADHD in School Children

Who Can Participate

Age: 9Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents with a diagnosis of ADHD
  • Control children without an ADHD diagnosis
  • Ages 9 to 18 years
  • Able to participate in multiple study visits over several weeks
Not Eligible

You will not qualify if you...

  • Intellectual disability
  • Psychosis
  • Severe depression
  • Severe anxiety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 5 months

Participants will undergo a double-blind crossover study including sessions with placebo medication and sham stimulation, active medication without stimulation, and active stochastic vestibular stimulation without medication. Control participants will experience sham and active stimulation without medication.

3 visits spaced 2 to 3 weeks apart

Follow-up

Duration - Up to 10 weeks after treatment sessions

Participants will evaluate the auditory noise application in a normal school setting and complete cognitive and neurological tests to assess effects of the interventions.

Visits aligned with cognitive testing sessions

Trial Site Locations

Total: 1 location

1

Child and Adolescent Psychiatry, Department of Clinical Sciences Lund, Lund University

Lund, Skåne County, Sweden, 221 85

Actively Recruiting

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Research Team

P

Peik Gustafsson, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

5

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