ClinicalTrials.gg
CompletedNCT07376902WHITE NOISEUpdated Jan 29, 2026

White Noise in SLD and ADHD

An interventional study of White noise and No white noise in ADHD - Attention Deficit Disorder With Hyperactivity, Specific Learning Disorder and Specific Learning Disability, sponsored by IRCCS San Raffaele Roma. Completed at 1 site in Italy. Open to participants aged 8 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by IRCCS San Raffaele Roma · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled May 2024, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
8 Years to 13 Years
Sex
All
01

Study 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.
02

Conditions studied

  • ADHD - Attention Deficit Disorder With Hyperactivity
  • Specific Learning Disorder
  • Specific Learning Disability
03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's enrollment of 30 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

IRCCS San Raffaele Roma is the lead sponsor of 71 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 criteria.

Exclusion criteria

Exclusion Criteria:

  • Genetic disorders or sensory deficits.
  • Pharmacological treatments that could interfere with task performance (including methylphenidate or specific ADHD treatments).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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.

    Other: White noise · Other: No 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.

    Other: White noise · Other: No white noise

Interventions

  • OtherWhite noise

    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.

  • OtherNo white noise

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

07

Study locations

1 site
  • IRCCS San Raffaele
    Rome, RM 00166, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Nov 2025, 18 months.

Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 18 months is below that.

Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2025
First posted
Jan 29, 2026
StartActual
May 23, 2024
Primary completionActual
Nov 30, 2025
CompletionActual
Nov 30, 2025
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07376902
Lead sponsor
IRCCS San Raffaele Roma
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
May 23, 2024
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025
Last update
Jan 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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