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Auditory Slow Wave Enhancement After Concussion

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Primary completion date: Dec 2023 to Mar 31, 2026
    • Study completion date: May 2024 to Mar 31, 2026
    v5
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Oct 2023 to Dec 2023
    • Study completion date: Mar 2024 to May 2024
    • Start date changed from estimate of May 2021 to May 31, 2021
  4. Start date: Mar 2021 to May 2021v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT04770116
Lead Sponsor University Children's Hospital, Zurich
Collaborators: ETH Zurich, University of Zurich
Conditions
(from sponsor)		 Concussion Post Syndrome
Related terms Post-Concussion Syndrome
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov