ADHDNCT03425669
Acoustic and Vestibular Noise as Possible Non-pharmacological Treatment of ADHD in School Children
A study testing Stochastic Vestibular Stimulation and Active medication in people with ADHD, run by Lund University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Stochastic Vestibular Stimulation and Active medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2019to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Child and Adolescent Psychiatry, Department of Clinical Sciences Lund, Lund University
Lund, Skåne County, 221 85
Peik Gustafsson, MD, PhD, +46736250674, Peik.Gustafsson@med.lu.se
About this study
Official title: Acoustic and Vestibular Noise as Possible Non-pharmacological Treatments of ADHD in School Children
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.
Read more
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.
Read the detailed description
Attention Deficit Hyperactivity disorder (ADHD) is one of the most frequent childhood disorders with an estimated prevalence of about 5-7% (e.g. Ullebo et al., 2012). Today the most common treatment approach is stimulant medication, e.g. methylphenidate (Greenhill et al., 2002; Wigal et al., 2011). However there are many concerns about medication: i) best dose for cognitive functioning and adapted school behavior differs (Hale et al., 2011), ii) it is not even evident that medication improves learning processes (Molina et al., 2009), iii) concerns regarding potential for drug abuse (Gordon et al., 2004); and iv) uncertainties regarding long term effects of drug use on the developing brain (Andersen, 2005).
In both national and international guidelines of ADHD care multimodal treatment is recommended (Young \& Amarasinghe, 2010), but most patients only receive pharmacological treatment, sometimes in combination with parent training. If auditory or vestibular noise, as the present project suggests, could be a complement or an alternative to stimulant medication it could fundamentally change the treatment of ADHD and the school situation for those children.
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). Inattentive and low achieving school children have been shown to improve their memory recall when exposed to noise, whereas attentive and high achieving children perform worse during noise exposure (Helps et al., 2014; Söderlund \& Sikström, 2008, 2012; Söderlund et al., 2010).
Vestibular noise benefit: Vestibular stimulation has since long been demonstrated to increase hippocampal activity and hippocampus is well demonstrated to be of crucial importance in detecting and holding on to spatial targets showing that hippocampus is of fundamental for both spatial orientation and learning in general (Moser et al., 2015). Therefore it is not surprising that external stochastic vestibular stimulation (SVS) exerts beneficial effects in different domains, e.g. balance in healthy astronauts (Mulavara et al., 2011), in Parkinson patients (Pal et al., 2009; Samoudi et al., 2014) and response times in continuous performance task (Yamamoto et al., 2005). The theory about noise benefit is thoroughly described by Sikström and Söderlund (2007). 1. The first objective is to systematically evaluate the effects of stochastic vestibular noise on cognitive task performance and to compare these results with the ones of stimulant medication using a double blind RCT (Random Control Trial) design.
The second objective is to implement a practical application, to evaluate if auditory noise can be beneficial in an every day school setting by the use of an iPhone application (see: www.smartnoise.se).
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
- Being tested
- Stochastic Vestibular Stimulation, Sham stimulation, Active medication
- Keywords
- Acoustic and vestibular noise stimulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic Vestibular StimulationDevice
Also called Auditory white noise 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.
Sham stimulationDevice
Patients will receive sham stimulation in place of active vestibular stimulation.
Active medicationDrug
Also called Concerta, Ritalin, Methylphenidate, Equasym or Medikinet
Patients will be examined with and without medication.
| Study group | Role | What they receive |
|---|---|---|
| Placebo medication and sham stimulation | Active comparator | Patients will be randomly chosen to the group who will get a combination of placebo and sham stimulation. Receives: Device: Sham stimulation |
| Active medication | Active comparator | Patients are randomly chosen to the group who will get active medication without stimulation. Receives: Drug: Active medication |
| Active stimulation | Sham comparator | Patients are randomly chosen to the group who will get acitive stimulation without taking medicine. Receives: Device: Stochastic Vestibular Stimulation |
| Controls with sham stimulation | Active comparator | Controls without ADHD are randomly chosen to the group who will get sham stimulation. Receives: Device: Sham stimulation |
| Controls with active stimulation | Sham comparator | Controls without ADHD are randomly chosen to the group who will get active stimulation. Receives: Device: Stochastic Vestibular Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spanboard task
Test of visuo-spatial working memory
Measured: Ten weeks
AVLT
Auditory Verbal Learning Test
Measured: Ten weeks
Go No- go test
Test of impulse inhibition
Measured: Ten weeks
Secondary outcomes (3)
Soft- signs test
Test of minor neurological deficits
Measured: Ten weeks
Flower trail
Test of perception, fine motor function and motor planning
Measured: Ten weeks
Finger tapping task
Test of timing
Measured: Ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start1 May 2019
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients 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. 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 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peik Gustafsson, MD, PhD, Principal investigator, Department of clinical sciences, Lund Uniersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425669
- Sponsor's protocol ID
- Sponsor
- Status last verified
- Oct 2023
- First submitted
- 1 Feb 2018
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic and Vestibular Noise as Possible Non-pharmacological Treatments of ADHD in School Children
- ClinicalTrials.gov ID
- NCT03425669
- Acronym / sponsor ID
- Sponsor
- Conditions
- ADHD
- Keywords
- Acoustic and vestibular noise stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Attention Deficit Hyperactivity disorder (ADHD) is one of the most frequent childhood disorders with an estimated prevalence of about 5-7% (e.g. Ullebo et al., 2012). Today the most common treatment approach is stimulant medication, e.g. methylphenidate (Greenhill et al., 2002; Wigal et al., 2011). However there are many concerns about medication: i) best dose for cognitive functioning and adapted school behavior differs (Hale et al., 2011), ii) it is not even evident that medication improves learning processes (Molina et al., 2009), iii) concerns regarding potential for drug abuse (Gordon et al., 2004); and iv) uncertainties regarding long term effects of drug use on the developing brain (Andersen, 2005).
In both national and international guidelines of ADHD care multimodal treatment is recommended (Young \& Amarasinghe, 2010), but most patients only receive pharmacological treatment, sometimes in combination with parent training. If auditory or vestibular noise, as the present project suggests, could be a complement or an alternative to stimulant medication it could fundamentally change the treatment of ADHD and the school situation for those children.
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). Inattentive and low achieving school children have been shown to improve their memory recall when exposed to noise, whereas attentive and high achieving children perform worse during noise exposure (Helps et al., 2014; Söderlund \& Sikström, 2008, 2012; Söderlund et al., 2010).
Vestibular noise benefit: Vestibular stimulation has since long been demonstrated to increase hippocampal activity and hippocampus is well demonstrated to be of crucial importance in detecting and holding on to spatial targets showing that hippocampus is of fundamental for both spatial orientation and learning in general (Moser et al., 2015). Therefore it is not surprising that external stochastic vestibular stimulation (SVS) exerts beneficial effects in different domains, e.g. balance in healthy astronauts (Mulavara et al., 2011), in Parkinson patients (Pal et al., 2009; Samoudi et al., 2014) and response times in continuous performance task (Yamamoto et al., 2005). The theory about noise benefit is thoroughly described by Sikström and Söderlund (2007). 1. The first objective is to systematically evaluate the effects of stochastic vestibular noise on cognitive task performance and to compare these results with the ones of stimulant medication using a double blind RCT (Random Control Trial) design.
The second objective is to implement a practical application, to evaluate if auditory noise can be beneficial in an every day school setting by the use of an iPhone application (see: www.smartnoise.se).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
- Model description
- Patients 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. 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 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo medication and sham stimulation | Active comparator | Device: Sham stimulationPatients will be randomly chosen to the group who will get a combination of placebo and sham stimulation. |
| Active medication | Active comparator | Drug: Active medicationPatients are randomly chosen to the group who will get active medication without stimulation. |
| Active stimulation | Sham comparator | Device: Stochastic Vestibular StimulationPatients are randomly chosen to the group who will get acitive stimulation without taking medicine. |
| Controls with sham stimulation | Active comparator | Device: Sham stimulationControls without ADHD are randomly chosen to the group who will get sham stimulation. |
| Controls with active stimulation | Sham comparator | Device: Stochastic Vestibular StimulationControls without ADHD are randomly chosen to the group who will get active stimulation. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stochastic Vestibular StimulationAlso: Auditory white noise stimulationStochastic 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 | Active stimulation, Controls with active stimulation |
| Sham stimulationPatients will receive sham stimulation in place of active vestibular stimulation. | Device | Controls with sham stimulation, Placebo medication and sham stimulation |
| Active medicationAlso: Concerta, Ritalin, Methylphenidate, Equasym or MedikinetPatients will be examined with and without medication. | Drug | Active medication |
Primary outcome
Spanboard task
Time frame: Ten weeks
Test of visuo-spatial working memory
AVLT
Time frame: Ten weeks
Auditory Verbal Learning Test
Go No- go test
Time frame: Ten weeks
Test of impulse inhibition
3 secondary outcomes
Soft- signs test
Time frame: Ten weeks
Flower trail
Time frame: Ten weeks
Finger tapping task
Time frame: Ten weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peik Gustafsson, MD, PhD principal investigator
Department of clinical sciences, Lund Uniersity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stochastic Vestibular Stimulation and Active medication in people with ADHD, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peik Gustafsson, MD, PhD (+46736250674, Peik.Gustafsson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spanboard task (time frame: Ten weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.