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

NCT03425669 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-11

No results posted yet for this study

Summary

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

  • ADHD

Interventions

DEVICE

Stochastic Vestibular Stimulation

Stochastic vestibular stimulation will be given by electric stimulation through electrodes place over the mastoid processes behind each ear. Auditory stimulation with stochastic white noise will be administrated through ear phones.

DEVICE

Sham stimulation

Patients will receive sham stimulation in place of active vestibular stimulation.

DRUG

Active medication

Patients will be examined with and without medication.

Sponsors & Collaborators

  • Lund University

    lead OTHER

Principal Investigators

  • Peik Gustafsson, MD, PhD · Department of clinical sciences, Lund Uniersity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2024-05-31
Completion
2027-05-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03425669 on ClinicalTrials.gov