Clinical Trial

Auditory Slow Wave Enhancement After Concussion

Recruiting
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Record status
This record was last updated December 9, 2024 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
The prevalence of a traumatic brain injury (TBI) in children and adolescents is around 30% with 70-90% being classified as mild (concussion). Because the brain of a child is still developing, a TBI can have devastating effects and possibly creates lifetime challenges. Sleep seems to play an important role in the post-concussion recovery process. Auditory stimulation during sleep has been shown to reliably boost slow waves, a solid marker for the depth of sleep, and can thus be used to deepen sleep. This study aims to investigate the effects of sleep enhancement via auditory stimulation on recovery after a concussion in children and adolescents in their home. Therefore, half of the patients receive one week of auditory stimulation during deep sleep at their home using a mobile device. The other half follows the same study protocol, but no tones are administered (sham). Cognitive tests as well as symptom questionnaires are used to assess the recovery process. It is hypothesized that the patients in the intervention group will recover better than the ones who haven't received the intervention. Additionally, a group of children and adolescents who never sustained a concussion is included as a control.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-02-22; most recent amendment 2024-12-04.
Status change: Not Yet Recruiting → Recruiting 2021-09-28
Trial Details
NCT Number NCT04770116
Lead Sponsor University Children's Hospital, Zurich
Collaborators: ETH Zurich, University of Zurich
Conditions Concussion Post Syndrome
Enrollment 120 participants
Start Date 2021-05-31
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-09