Actively Recruiting
Auditory Slow Wave Enhancement After Concussion
Led by University Children's Hospital, Zurich · Updated on 2024-12-09
120
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
U
University Children's Hospital, Zurich
Lead Sponsor
E
ETH Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Auditory Slow Wave Enhancement After Concussion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent documented by signature
- Age between 6 and 18 years
- Good knowledge of German by the patient and at least one legal representative
- Patients must have been diagnosed with a concussion by a medical doctor at the University Children's Hospital Zurich
You will not qualify if you...
- Preterm birth before 37 gestational weeks
- Diagnosed hearing disorder
- Psychiatric, syndromal, or neurological pre-existing condition except previous concussion
- Skin disorder or problem in the face or ear area requiring treatment
- Use of neuroactive substances
- For patients: concomitant injury requiring intense pain medication, prolonged hospital stay, or limiting use of the dominant hand
- For patients: previous moderate to severe traumatic brain injury
- For controls: injury to dominant hand, head, arm, or leg
- For controls: previous traumatic brain injury of any severity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Children's Hospital Zurich
Zurich, Switzerland, 8032
Actively Recruiting
Research Team
R
Reto Huber, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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