Actively Recruiting

Phase Not Applicable
Age: 9Years - 18Years
All Genders
Healthy Volunteers
NCT03425669

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

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

70

Participants Needed

1

Research Sites

421 weeks

Total Duration

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AI-Summary

What this Trial Is About

Noise benefit in ADHD Auditory noise benefit: The original findings from our research group, that auditory noise enhances cognitive performance in inattentive children without diagnosis as well as children with an ADHD diagnosis, have been replicated several times (Baijot et al., 2016; Söderlund et al., 2016; Söderlund \& Nilsson Jobs, 2016; Söderlund et al., 2007). In a new study, the benefit of noise was shown to be in parity with or even larger than the benefit of pharmacological ADHD treatment on two cognitive tasks, episodic word recall and visuo-spatial working memory task. In the study a group of children diagnosed with ADHD were tested on and off medication, at separate occasions, in noisy vs. silent environments while performing the tasks (Söderlund, Björk et al., 2016). Participants and recruitment: Participants with an ADHD diagnosis using medication will be recruited from Child and Adolescent Psychiatry in Lund and Malmö. Typically developing children (TDC) and inattentive children without diagnosis will be recruited from schools in collaboration with the municipality. Experimental design: All participants will perform a double-blind placebo cross over control study. ADHD participants will perform the entire test battery at three occasions with 2-3 weeks intermission in between tests. One occasion with placebo medication and sham SVS stimulation; one occasion with active SVS stimulation; and one occasion with active medication. TD children will only be tested twice while they will not be given any medication or placebo and just perform under SVS vs. sham conditions. Test battery: 1) Episodic memory will be tested trough Auditory Verbal Learning Test (AVLT) (e.g. Dige et al., 2008). 2) Visuo-spatial working memory will be tested through the Spanboard task (Westerberg et al., 2004). 3) Motor-neurological investigation. 4) A finger tapping task. 5) Evaluation of an iPhone auditory noise application in a normal school setting. Our research group has developed an iPhone application (www.smartnoise.se) that is available at App-store right now. The study will last for about 5 months and participants will be 50 voluntary secondary school pupils that have documented attention difficulties as judged by their teachers. The application will be evaluated both by pupils, teachers and parents.

CONDITIONS

Official 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
Not Eligible

You will not qualify if you...

  • Intellectual disability
  • Psychosis
  • Severe depression
  • Severe anxiety

AI-Screening

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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

CONTACT

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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