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Acoustic and Vestibular Noise as Possible Non-pharmacological Treatment of ADHD in School Children

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated October 11, 2023 (before its estimated May 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: May 31, 2023 to May 31, 2024v6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Primary completion date: May 31, 2020 to May 31, 2023
    • Study completion date: May 31, 2020 to May 31, 2027
    • Study description expanded, about 3 words
    v4
  4. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary and study completion dates: May 31, 2019 to May 31, 2020
    • Start date changed from estimate of Apr 28, 2019 to May 1, 2019
    • Interventions: Central Stimulant (Drug), Placebo oral capsule (Drug), Sham stimulation (Device), Stochastic Vestibular Stimulation (Device) to Active medication (Drug), Sham stimulation (Device), Stochastic Vestibular Stimulation (Device)
    • Study description expanded, about 745 words
  5. Notable Start date: Feb 28, 2018 to Apr 28, 2019v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
411 trials monitored
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Noise benefit in ADHD Auditory noise benefit: The original findings from our research group, that auditory noise enhances cognitive performance in inattentive children without diagnosis as well as children with an ADHD diagnosis, have been replicated several times (Baijot et al., 2016; Söderlund et al., 2016; Söderlund \& Nilsson Jobs, 2016; Söderlund et al., 2007). In a new study, the benefit of noise was shown to be in parity with or even larger than the benefit of pharmacological ADHD treatment on two cognitive tasks, episodic word recall and visuo-spatial working memory task. In the study a group of children diagnosed with ADHD were tested on and off medication, at separate occasions, in noisy vs. silent environments while performing the tasks (Söderlund, Björk et al., 2016). Participants and recruitment: Participants with an ADHD diagnosis using medication will be recruited from Child and Adolescent Psychiatry in Lund and Malmö. Typically developing children (TDC) and inattentive children without diagnosis will be recruited from schools in collaboration with the municipality. Experimental design: All participants will perform a double-blind placebo cross over control study. ADHD participants will perform the entire test battery at three occasions with 2-3 weeks intermission in between tests. One occasion with placebo medication and sham SVS stimulation; one occasion with active SVS stimulation; and one occasion with active medication. TD children will only be tested twice while they will not be given any medication or placebo and just perform under SVS vs. sham conditions. Test battery: 1) Episodic memory will be tested trough Auditory Verbal Learning Test (AVLT) (e.g. Dige et al., 2008). 2) Visuo-spatial working memory will be tested through the Spanboard task (Westerberg et al., 2004). 3) Motor-neurological investigation. 4) A finger tapping task. 5) Evaluation of an iPhone auditory noise application in a normal school setting. Our research group has developed an iPhone application (www.smartnoise.se) that is available at App-store right now. The study will last for about 5 months and participants will be 50 voluntary secondary school pupils that have documented attention difficulties as judged by their teachers. The application will be evaluated both by pupils, teachers and parents.
Trial Details
NCT Number NCT03425669
Lead Sponsor Lund University
Conditions
(from sponsor)
ADHD
Related terms Attention Deficit Disorder with Hyperactivity
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov