Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03425669 |
| Other study ID # |
Sponsor |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2019 |
| Est. completion date |
May 31, 2027 |
Study information
| Verified date |
October 2023 |
| Source |
Lund University |
| Contact |
Peik Gustafsson, MD, PhD |
| Phone |
+46736250674 |
| Email |
Peik.Gustafsson[@]med.lu.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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; 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.
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.
