RecruitingNot ApplicableNCT04770116

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


Sponsor

University Children's Hospital, Zurich

Enrollment

120 participants

Start Date

May 31, 2021

Study Type

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

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Auditory Stimulation for people with concussion post syndrome. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAuditory Stimulation

The device records biosignals and precisely plays tones to enhance sleep slow waves.


Locations(1)

University Children's Hospital Zurich

Zurich, Switzerland

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NCT04770116