Auditory Slow Wave Enhancement After Concussion

ConditionConcussion Post Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-18

SponsorUniversity Children's Hospital, Zurich

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: Control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

Cognitive Performance - attention

Assessed by standardized test (normative values).

Time frame

Measured one month after study inclusion.

Cognitive Performance - processing speed

Assessed by standardized test (normative values).

Time frame

Measured one month after study inclusion.

Cognitive Performance - executive function

Assessed by standardized test (normative values).

Time frame

Measured one month after study inclusion.

Secondary outcomes

Subjective recovery

Assessed by standardized symptom questionnaires.

Time frame

Measured at baseline, one week later (intermediate assessment), one month later (follow-up 1) and six months later (follow-up 2).

Algorithm performance

The algorithm flags which are produced by the mobile device used for the auditory stimulation (i.e. sleep detection flags, stimulation flags). They are used to investigate the algorithm performance for each subject.

Time frame

Recorded during seven nights of stimulation or sham (intervention week).

Neurological outcome

Measured using Magnetic Resonance Imaging (standard structural and hemodynamic imaging, DTI, and susceptibility weighting) to investigate the neurological outcome.

Time frame

One month after study inclusion (follow-up 1).

Injury characteristics

Only for patients: Injury characteristics collected from the Hospital Information System that might influence baseline and follow-up measures and their change over time.

Time frame

baseline, pre-intervention

Other outcomes

Intervention tolerability

Measured using an intervention evaluation questionnaire (self-designed).

Time frame

After the intervention week (one week after study inclusion).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Children's Hospital, Zurich

Lead sponsor

ETH Zurich

Collaborator

University of Zurich

Collaborator

Source ClinicalTrials.gov

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