Auditory Slow Wave Enhancement After Concussion

Concussion Post Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04770116
• Other study ID #: 2020-00253
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: May 2024

Study information

• Verified date: March 2023
• Source: University Children's Hospital, Zurich
• Contact: Reto Huber, Prof.
• Phone: 0041442668160
• Email: reto.huber[@]kispi.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Concussion Post Syndrome
• Post-Concussion Syndrome

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich	ETH Zurich, University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention tolerability	Measured using an intervention evaluation questionnaire (self-designed).	After the intervention week (one week after study inclusion).
Primary	Cognitive Performance - attention	Assessed by standardized test (normative values).	Measured one month after study inclusion.
Primary	Cognitive Performance - processing speed	Assessed by standardized test (normative values).	Measured one month after study inclusion.
Primary	Cognitive Performance - executive function	Assessed by standardized test (normative values).	Measured one month after study inclusion.
Secondary	Subjective recovery	Assessed by standardized symptom questionnaires.	Measured at baseline, one week later (intermediate assessment), one month later (follow-up 1) and six months later (follow-up 2).
Secondary	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.	Recorded during seven nights of stimulation or sham (intervention week).
Secondary	Neurological outcome	Measured using Magnetic Resonance Imaging (standard structural and hemodynamic imaging, DTI, and susceptibility weighting) to investigate the neurological outcome.	One month after study inclusion (follow-up 1).
Secondary	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.	baseline, pre-intervention
Secondary	Other possible moderators of the Intervention	For example age and socio-economic status.	Collected at the baseline assessment.
Secondary	EEG power	Power in frequency bands (delta, theta, alpha, beta, gramma).	Recorded during the intervention week.
Secondary	Sleep stages	EEG, EOG and EMG used for sleep scoring (sleep stages).	Recorded during the intervention week.
Secondary	Sleep EEG characteristics	Characteristics of sleep EEG Features (slow waves, spindles).	Recorded during the intervention week.
Secondary	Subjective sleep	Assessed by standardized questionnaire	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)).
Secondary	Actigraphy	Measured by GENEActiv (activity bouts).	Recorded during the intervention week.
Secondary	Objective and subjective sleep measures	Sleep measured by EEG and actigraphy (objective) as well as questionnaires (subjective)	Recorded at all study visits over a period of six months (baseline assessment, intervention week, follow-up 1 and follow-up 2)..