NCT04770116 Auditory Slow Wave Enhancement After Concussion
| NCT ID | NCT04770116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Children's Hospital, Zurich |
| Condition | Concussion Post Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-05-31 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-05-31 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Usage of neuroactive substances * Patients: Concomitant injury that requires intense pain medication or a prolonged hospital stay, or that causes limited use of the dominant Hand * Patients: Previous moderate-severe TBI * Controls: Injury of the dominant hand, on head, arm, or leg * Controls: Previous TBI (of any severity) Additional inclusion criteria for the optional MRI measurement for both groups: * Age at least 8 years * Fulfilment of all MRI safety criteria * The participant and the legal representative would want to know about incidental findings. * Girls: No pregnancy or breast feeding.
Contact & Investigator
Reto Huber, Prof.
PRINCIPAL INVESTIGATOR
University Children's Hospital, Zurich
Frequently Asked Questions
Who can join the NCT04770116 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Concussion Post Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04770116 currently recruiting?
Yes, NCT04770116 is actively recruiting participants. Contact the research team at reto.huber@kispi.uzh.ch for enrollment information.
Where is the NCT04770116 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT04770116 clinical trial?
NCT04770116 is sponsored by University Children's Hospital, Zurich. The principal investigator is Reto Huber, Prof. at University Children's Hospital, Zurich. The trial plans to enroll 120 participants.