Clinical trial NCT04770116: Auditory Slow Wave Enhancement After Concussion
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Concussion Post Syndrome
Keywords: sleep
auditory stimulation
post-concussive symptoms
in-home EEG
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: University of Zurich
First posted: 2021-02-25
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Cognitive Performance - attention
timeFrame: Measured one month after study inclusion.
measure: Cognitive Performance - processing speed
timeFrame: Measured one month after study inclusion.
measure: Cognitive Performance - executive function
timeFrame: Measured one month after study inclusion.
Secondary outcomes:
measure: Subjective recovery
timeFrame: Measured at baseline, one week later (intermediate assessment), one month later (follow-up 1) and six months later (follow-up 2).
measure: Algorithm performance
timeFrame: Recorded during seven nights of stimulation or sham (intervention week).
measure: Neurological outcome
timeFrame: One month after study inclusion (follow-up 1).
measure: Injury characteristics
timeFrame: baseline, pre-intervention
measure: Other possible moderators of the Intervention
timeFrame: Collected at the baseline assessment.
measure: EEG power
timeFrame: Recorded during the intervention week.
measure: Sleep stages
timeFrame: Recorded during the intervention week.
measure: Sleep EEG characteristics
timeFrame: Recorded during the intervention week.
measure: Subjective sleep
timeFrame: 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)).
measure: Actigraphy
timeFrame: Recorded during the intervention week.
measure: Objective and subjective sleep measures
timeFrame: Recorded at all study visits over a period of six months (baseline assessment, intervention week, follow-up 1 and follow-up 2)..
Other outcomes:
measure: Intervention tolerability
timeFrame: After the intervention week (one week after study inclusion).
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Reto Huber, Prof.
role: PRINCIPAL_INVESTIGATOR
References: