White Noise in SLD and ADHD (WHITE NOISE)

IRCCS San Raffaele Roma

Status: Completed

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

Treatments: Other: White noise; Other: No white noise

Study type: Interventional

Funder types: Other

Identifiers

NCT07376902

137/SR/24

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

ADHD

Experimental group

Description:

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.

Treatment:

Other: No white noise

Other: White noise

ADHD + SLD

Experimental group

Description:

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.

Treatment:

Other: No white noise

Other: White noise