NCT03425669 Acoustic and Vestibular Noise as Possible Non-pharmacological Treatment of ADHD in School Children
| NCT ID | NCT03425669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lund University |
| Condition | ADHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2024-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2019-05-01 with a primary completion date of 2024-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: Children and adolescents with a diagnosis of ADHD and control children without at diagnosis. \- Exclusion Criteria: Intellectual disability, psychosis, severe depression or anxiety \-
Contact & Investigator
Peik Gustafsson, MD, PhD
PRINCIPAL INVESTIGATOR
Department of clinical sciences, Lund Uniersity
Frequently Asked Questions
Who can join the NCT03425669 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 18 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03425669 currently recruiting?
Yes, NCT03425669 is actively recruiting participants. Contact the research team at Peik.Gustafsson@med.lu.se for enrollment information.
Where is the NCT03425669 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT03425669 clinical trial?
NCT03425669 is sponsored by Lund University. The principal investigator is Peik Gustafsson, MD, PhD at Department of clinical sciences, Lund Uniersity. The trial plans to enroll 70 participants.