Enhancing sleep recovery after concussion in children
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
This study is testing if using sound while kids sleep can help them recover better from a concussion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT04770116 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 to 18 years who have been diagnosed with a concussion.
Not a fit: Patients with pre-existing neurological conditions or severe traumatic brain injuries may not benefit from this study.
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 performed: While the specific approach of auditory stimulation during sleep is novel, similar studies have shown promising results in enhancing sleep quality and cognitive recovery.
Eligibility criteria
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 this trial is running
Zurich
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.