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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 18
Healthy Volunteers: t
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Locations
Other Locations
Sweden
Child and Adolescent Psychiatry, Department of Clinical Sciences Lund, Lund University
RECRUITING
Lund
Contact Information
Primary
Peik Gustafsson, MD, PhD
Peik.Gustafsson@med.lu.se
+46736250674
Time Frame
Start Date: 2019-05-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 70
Treatments
Active_comparator: Placebo medication and sham stimulation
Patients will be randomly chosen to the group who will get a combination of placebo and sham stimulation.
Active_comparator: Active medication
Patients are randomly chosen to the group who will get active medication without stimulation.
Sham_comparator: Active stimulation
Patients are randomly chosen to the group who will get acitive stimulation without taking medicine.
Active_comparator: Controls with sham stimulation
Controls without ADHD are randomly chosen to the group who will get sham stimulation.
Sham_comparator: Controls with active stimulation
Controls without ADHD are randomly chosen to the group who will get active stimulation.
Sponsors
Leads: Lund University

This content was sourced from clinicaltrials.gov