Acoustic and Vestibular Noise as Possible Non-pharmacological Treatment of ADHD in School Children
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2018
CompletedFirst Posted
Study publicly available on registry
February 7, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
ExpectedOctober 11, 2023
October 1, 2023
5.1 years
February 1, 2018
October 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Spanboard task
Test of visuo-spatial working memory
Ten weeks
AVLT
Auditory Verbal Learning Test
Ten weeks
Go No- go test
Test of impulse inhibition
Ten weeks
Secondary Outcomes (3)
Soft- signs test
Ten weeks
Flower trail
Ten weeks
Finger tapping task
Ten weeks
Study Arms (5)
Placebo medication and sham stimulation
ACTIVE COMPARATORPatients will be randomly chosen to the group who will get a combination of placebo and sham stimulation.
Active medication
ACTIVE COMPARATORPatients are randomly chosen to the group who will get active medication without stimulation.
Active stimulation
SHAM COMPARATORPatients are randomly chosen to the group who will get acitive stimulation without taking medicine.
Controls with sham stimulation
ACTIVE COMPARATORControls without ADHD are randomly chosen to the group who will get sham stimulation.
Controls with active stimulation
SHAM COMPARATORControls without ADHD are randomly chosen to the group who will get active stimulation.
Interventions
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.
Patients will receive sham stimulation in place of active vestibular stimulation.
Patients will be examined with and without medication.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
Study Sites (1)
Child and Adolescent Psychiatry, Department of Clinical Sciences Lund, Lund University
Lund, Skåne County, 221 85, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peik Gustafsson, MD, PhD
Department of clinical sciences, Lund Uniersity
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Participants will be randomized to placebo or stimulant medication during assessments. Participants will be unaware if they will get sham stimulation or SVS (but not the test administrator).
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2018
First Posted
February 7, 2018
Study Start
May 1, 2019
Primary Completion
May 31, 2024
Study Completion (Estimated)
May 31, 2027
Last Updated
October 11, 2023
Record last verified: 2023-10