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.
In total, 120 participants are planned: 60 patients (30 intervention, 30 sham) and 60 controls (30 intervention, 30 sham). This was estimated from a power analysis and based on previous results. Patients are recruited from the University Children's Hospital Zurich. At first, the participants will complete a baseline assessment of neuropsychological measures (cognitive tests and questionnaires). After completion of the baseline assessment, the participants receive deep sleep enhancement with auditory stimulation for seven nights, but half of them will only receive sham stimulation (device application, but no stimulation). Additionally, they wear an actigraph throughout the whole week. Afterwards, they fill in again some questionnaires (intermediate assessment). One month after study inclusion, the first follow-up will take place where neuropsychological and (optionally) neurological measures will be collected. The second follow-up takes place six months after study inclusion and involves again filling in questionnaires about post-concussive symptoms. The study will be monitored regularly in terms of data validation and source data verification. Adverse events and device deficiencies are carefully documented and reported according to the guidelines of swissmedic and the responsible ethics committee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
The device records biosignals and precisely plays tones to enhance sleep slow waves.
University Children's Hospital Zurich
Zurich, Switzerland
RECRUITINGCognitive 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.
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 possible moderators of the Intervention
For example age and socio-economic status.
Time frame: Collected at the baseline assessment.
EEG power
Power in frequency bands (delta, theta, alpha, beta, gramma).
Time frame: Recorded during the intervention week.
Sleep stages
EEG, EOG and EMG used for sleep scoring (sleep stages).
Time frame: Recorded during the intervention week.
Sleep EEG characteristics
Characteristics of sleep EEG Features (slow waves, spindles).
Time frame: Recorded during the intervention week.
Subjective sleep
Assessed by standardized questionnaire
Time frame: Collected throughout the whole study participation, in total 6 months (baseline, one week later (intermediate assessment), one month later (follow-up 1) and six months later (follow-up 2)).
Actigraphy
Measured by GENEActiv (activity bouts).
Time frame: Recorded during the intervention week.
Objective and subjective sleep measures
Sleep measured by EEG and actigraphy (objective) as well as questionnaires (subjective)
Time frame: Recorded at all study visits over a period of six months (baseline assessment, intervention week, follow-up 1 and follow-up 2)..
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