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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Switzerland
University Children's Hospital Zurich
RECRUITING
Zurich
Contact Information
Primary
Reto Huber, Prof.
reto.huber@kispi.uzh.ch
0041442668160
Time Frame
Start Date: 2021-05-31
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 120
Treatments
Experimental: Intervention group
Participants in this group will receive all-night auditory stimulation during sleep over one week using a portable, in-home device (MHSL-SleepBand).
Sham_comparator: Control group
Participants in this group will receive sham-stimulation, i.e. the device will be applied (biosignals will be recorded), but no tones will be played.
Related Therapeutic Areas
Sponsors
Collaborators: ETH Zurich, University of Zurich
Leads: University Children's Hospital, Zurich

This content was sourced from clinicaltrials.gov