Auditory Slow Wave Enhancement After Concussion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorUniversity Children's Hospital, Zurich

About this trial

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.

Eligibility criteria

Qualifiers

Informed Consent as documented by signature

Age between 6 and 18 years

Good knowledge of German of the patient and at least one legal representative

Patients: Presentation to the Emergency of the University Children's Hospital Zurich because of a concussion (diagnosed by medical doctor)

Disqualifiers

Preterm birth (< 37 gestational weeks)

Diagnosed hearing disorder

Psychiatric, syndromal, or neurological pre-existing condition (except for previous concussion)

Skin disorder/skin problem in the face/ear area that requires Treatment

Trial design

Treatments tested in this trial

  • Auditory Stimulation

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Children's Hospital, Zurich

Lead sponsor

ETH Zurich

Collaborator

University of Zurich

Collaborator