- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07376902
White Noise in SLD and ADHD (WHITE NOISE)
Effects of White Noise on Academic Skills in Children With ADHD and Specific Learning Disorders: New Perspectives for Personalised Rehabilitation and Educational Intervention
White noise has been shown to improve working memory and attention in children diagnosed with ADHD . These cognitive abilities are fundamental to the acquisition of reading and writing skills. Therefore, the aim of the present study is to evaluate the effects of white noise on reading and writing performance in children with a diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) and Specific Learning Disorder (SLD) attending the first and second cycles of primary school.
The study is a randomized crossover clinical trial comprising five sequential phases. Each participant completes two standardized assessment sessions, one with white noise and one without, in a randomized order, separated by a four-week interval.
- Phase I (Recruitment and Screening): potential participants are identified and assessed for eligibility at the Centro di Riabilitazione San Raffaele Pisana in Rome.
- Phase II (Diagnostic Grouping): eligible children are assigned to one of two diagnostic groups based on their clinical profile (Group SLD + ADHD or Group SLD-only).
- Phase III (Randomized Sequencing): Within each diagnostic group, participants are randomly allocated to one of two exposure sequences to counterbalance order effects (White-noise → No-noise, or No-noise → White-noise).
- Phase IV (First Assessment Session): standardized assessment under randomized conditions, with or without white noise.
- Phase V (Second Assessment Session): standardized assessment, conducted four weeks later, with or without white noise according to the previous randomization.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RM
-
Rome, RM, Italy, 00166
- IRCCS San Raffaele
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Intelligence Quotient (IQ), assessed using the Wechsler Intelligence Scales (WISC-IV), ≥ 70.
- Age between 8 and 13 years.
- Diagnosis of SLD, with or without comorbid ADHD according to DSM-5 criteria.
Exclusion Criteria:
- Genetic disorders or sensory deficits.
- Pharmacological treatments that could interfere with task performance (including methylphenidate or specific ADHD treatments).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ADHD
Subjects are enrolled according to the following criteria: Intelligence Quotient (IQ), assessed using the Wechsler Intelligence Scales (WISC-IV), ≥ 70.
Age between 8 and 13 years.
Diagnosis of ADHD according to DSM-5 criteria.
|
Reading and writing standardized assessment with white noise.
The white noise, created for this study by an audio engineer, is played through a speaker positioned approximately 1 m from the participant, at an intensity of 60-65 dB within the designated testing environment.
At the start of each session, participants are informed of its presence to prevent any potential discomfort.
This adaptation phase lasts approximately 2-3 minutes.
Reading and writing standardized assessment in the absence of white noise.
|
|
Experimental: ADHD + SLD
Subjects are enrolled according the following criteria: Intelligence Quotient (IQ), assessed using the Wechsler Intelligence Scales (WISC-IV), ≥ 70.
Age between 8 and 13 years.
Diagnosis of SLD with comorbid ADHD according to DSM-5 criteria.
|
Reading and writing standardized assessment with white noise.
The white noise, created for this study by an audio engineer, is played through a speaker positioned approximately 1 m from the participant, at an intensity of 60-65 dB within the designated testing environment.
At the start of each session, participants are informed of its presence to prevent any potential discomfort.
This adaptation phase lasts approximately 2-3 minutes.
Reading and writing standardized assessment in the absence of white noise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading speed
Time Frame: 4 weeks
|
For the passage-reading test and the word- and nonword-reading tasks: reading speed, expressed in syllables per second (syl/sec) was calculated by dividing the total number of syllables in the stimulus by the total reading time, measured in seconds.
|
4 weeks
|
|
Reading Accuracy
Time Frame: 4 weeks
|
For the passage-reading test and the word- and nonword-reading tasks reading accuracy was defined as the total number of errors produced.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Communication Disorders
- Learning Disabilities
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Specific Learning Disorder
- Attention Deficit Disorder with Hyperactivity
Other Study ID Numbers
- 137/SR/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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