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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cognitive Performance - processing speed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study helpers
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Intervention group
Participants in this group will receive all-night auditory stimulation during sleep over one week using a portable, in-home device (MHSL-SleepBand).
干预措施: Auditory Stimulation (Device)
Control group
Participants in this group will receive sham-stimulation, i.e. the device will be applied (biosignals will be recorded), but no tones will be played.
干预措施: Auditory Stimulation (Device)
结局指标
主要结局
Cognitive Performance - processing speed
时间窗: Measured one month after study inclusion.
Assessed by standardized test (normative values).
Cognitive Performance - attention
时间窗: Measured one month after study inclusion.
Assessed by standardized test (normative values).
Cognitive Performance - executive function
时间窗: Measured one month after study inclusion.
Assessed by standardized test (normative values).
次要结局
- Actigraphy(Recorded during the intervention week.)
- Algorithm performance(Recorded during seven nights of stimulation or sham (intervention week).)
- Other possible moderators of the Intervention(Collected at the baseline assessment.)
- Injury characteristics(baseline, pre-intervention)
- EEG power(Recorded during the intervention week.)
- Sleep EEG characteristics(Recorded during the intervention week.)
- Subjective sleep(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)).)
- Subjective recovery(Measured at baseline, one week later (intermediate assessment), one month later (follow-up 1) and six months later (follow-up 2).)
- Neurological outcome(One month after study inclusion (follow-up 1).)
- Sleep stages(Recorded during the intervention week.)
- Objective and subjective sleep measures(Recorded at all study visits over a period of six months (baseline assessment, intervention week, follow-up 1 and follow-up 2)..)