Enhancing sleep recovery after concussion in children
Official title: 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
Run by University Children's Hospital, Zurich · NCT04770116 · Data updated 2026-11-12
This study is testing if using sound while kids sleep can help them recover better from a concussion.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Status | Recruiting |
| Started | May 31, 2021 |
| Main results expected | March 31, 2026 |
| Study ends | March 31, 2026 |
| Registry record updated | December 9, 2024 |
| Trial ID | NCT04770116 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and adolescents aged 6 to 18 years who have been diagnosed with a concussion.
✕Probably not a fit
Patients with pre-existing neurological conditions or severe traumatic brain injuries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of auditory stimulation during sleep on recovery from concussion in children and adolescents. Participants aged 6 to 18 years who have experienced a concussion will be randomly assigned to receive either auditory stimulation or sham stimulation for one week while sleeping at home. The study will assess cognitive performance and post-concussive symptoms through questionnaires and tests at baseline, intermediate, and follow-up assessments. The goal is to determine if enhancing deep sleep can improve recovery outcomes after a concussion.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery times and outcomes for children suffering from post-concussion symptoms.
How similar studies have gone: While the specific approach of auditory stimulation during sleep is novel, similar studies have shown promising results in enhancing sleep quality and cognitive recovery.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University Children's Hospital Zurich
Zurich, Switzerland Recruiting
Study contacts
- Principal investigator: Reto Huber, Prof. — University Children's Hospital, Zurich
- Study coordinator: Reto Huber, Prof.
- Email: reto.huber@kispi.uzh.ch
- Phone: 0041442668160
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.