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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Peik Gustafsson, MD, PhD contact

+46736250674

Peik.Gustafsson@med.lu.se

Sweden1 site, 1 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

    Recruiting

Other trials in Sweden

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 groups in NCT03425669
Study groupRoleWhat they receive
Placebo medication and sham stimulationActive comparatorPatients will be randomly chosen to the group who will get a combination of placebo and sham stimulation.
Receives: Device: Sham stimulation
Active medicationActive comparatorPatients are randomly chosen to the group who will get active medication without stimulation.
Receives: Drug: Active medication
Active stimulationSham comparatorPatients are randomly chosen to the group who will get acitive stimulation without taking medicine.
Receives: Device: Stochastic Vestibular Stimulation
Controls with sham stimulationActive comparatorControls without ADHD are randomly chosen to the group who will get sham stimulation.
Receives: Device: Sham stimulation
Controls with active stimulationSham comparatorControls 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.

  1. Spanboard task

    Test of visuo-spatial working memory

    Measured: Ten weeks

  2. AVLT

    Auditory Verbal Learning Test

    Measured: Ten weeks

  3. Go No- go test

    Test of impulse inhibition

    Measured: Ten weeks

Secondary outcomes (3)
  1. Soft- signs test

    Test of minor neurological deficits

    Measured: Ten weeks

  2. Flower trail

    Test of perception, fine motor function and motor planning

    Measured: Ten weeks

  3. 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.

  1. First posted7 Feb 2018
  2. Study start1 May 2019
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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)
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

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.

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