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

Overview

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.

Interventions

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

Primary outcome measures

• Cognitive Performance - attention [Time frame: Measured one month after study inclusion.]
• Cognitive Performance - processing speed [Time frame: Measured one month after study inclusion.]
• Cognitive Performance - executive function [Time frame: Measured one month after study inclusion.]

Secondary outcome measures (11)

• Subjective recovery [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 [Time frame: Recorded during seven nights of stimulation or sham (intervention week).]
• Neurological outcome [Time frame: One month after study inclusion (follow-up 1).]
• Injury characteristics [Time frame: baseline, pre-intervention]
• Other possible moderators of the Intervention [Time frame: Collected at the baseline assessment.]
• EEG power [Time frame: Recorded during the intervention week.]
• Sleep stages [Time frame: Recorded during the intervention week.]
• Sleep EEG characteristics [Time frame: Recorded during the intervention week.]
• Subjective sleep [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 [Time frame: Recorded during the intervention week.]
• Objective and subjective sleep measures [Time frame: Recorded at all study visits over a period of six months (baseline assessment, intervention week, follow-up 1 and follow-up 2)..]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• University Children's Hospital Zurich — Zurich

Identifiers

NCT: NCT04770116 · 2020-00253

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗