IRCCS San Raffaele
Rome, RM, 00166, Italy
NCT Number: NCT07376902
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.
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Notify Me8 year–13 year
All sexes
Interventional
Not applicable
Rome, RM, 00166, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion 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.
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.
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.
IRCCS San Raffaele Roma
Other
Effects of White Noise on Academic Skills in Children With ADHD and Specific Learning Disorders: New Perspectives for Personalised Rehabilitation and Educational Intervention
Acronym: WHITE NOISE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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