White Noise in SLD and ADHD

NCT07376902 | Completed

• 1 other identifier: 137/SR/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity; Specific Learning Disorder; Specific Learning Disability

Outcome Measures

Primary Outcomes (2)

• Reading speed

  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

  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

Study Arms (2)

ADHD

EXPERIMENTAL

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.

Other: White noise; Other: No white noise

ADHD + SLD

EXPERIMENTAL

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.

Other: White noise; Other: No white noise

Interventions

No white noise OTHER

Reading and writing standardized assessment in the absence of white noise.

ADHD; ADHD + SLD

White noise OTHER

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.

ADHD; ADHD + SLD

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Genetic disorders or sensory deficits.
• Pharmacological treatments that could interfere with task performance (including methylphenidate or specific ADHD treatments).

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele

Rome, RM, 00166, Italy

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Specific Learning Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Learning Disabilities; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 29, 2026
• Study Start: May 23, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)