Auditory Slow Wave Enhancement After Concussion
The Effect of Sleep and Slow Wave Enhancement on Recovery From a Concussion in Children and Adolescents: A Longitudinal, Randomized, Double-Blind, and Sham-Controlled Study
University Children's Hospital, Zurich
120 participants
May 31, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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)
- 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.
Exclusion Criteria9
- 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)
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Interventions
The device records biosignals and precisely plays tones to enhance sleep slow waves.
Locations(1)
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NCT04770116