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NCT Number: NCT04770116

Auditory Slow Wave Enhancement After Concussion

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.

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Key information

Conditions

Concussion Post Syndrome Brain Concussion Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Post-Concussion Syndrome Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location status: Recruiting

Location contact

Reto Huber

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auditory Stimulation

Device

The device records biosignals and precisely plays tones to enhance sleep slow waves.

Primary outcomes

  1. Cognitive Performance - attention

    Time frame: Measured one month after study inclusion.

    Assessed by standardized test (normative values).

  2. Cognitive Performance - processing speed

    Time frame: Measured one month after study inclusion.

    Assessed by standardized test (normative values).

  3. Cognitive Performance - executive function

    Time frame: Measured one month after study inclusion.

    Assessed by standardized test (normative values).

Secondary outcomes

  1. 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).

    Assessed by standardized symptom questionnaires.

  2. Algorithm performance

    Time frame: Recorded during seven nights of stimulation or sham (intervention week).

    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.

  3. Neurological outcome

    Time frame: One month after study inclusion (follow-up 1).

    Measured using Magnetic Resonance Imaging (standard structural and hemodynamic imaging, DTI, and susceptibility weighting) to investigate the neurological outcome.

  4. Injury characteristics

    Time frame: baseline, pre-intervention

    Only for patients: Injury characteristics collected from the Hospital Information System that might influence baseline and follow-up measures and their change over time.

  5. Other possible moderators of the Intervention

    Time frame: Collected at the baseline assessment.

    For example age and socio-economic status.

  6. EEG power

    Time frame: Recorded during the intervention week.

    Power in frequency bands (delta, theta, alpha, beta, gramma).

  7. Sleep stages

    Time frame: Recorded during the intervention week.

    EEG, EOG and EMG used for sleep scoring (sleep stages).

  8. Sleep EEG characteristics

    Time frame: Recorded during the intervention week.

    Characteristics of sleep EEG Features (slow waves, spindles).

  9. 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)).

    Assessed by standardized questionnaire

  10. Actigraphy

    Time frame: Recorded during the intervention week.

    Measured by GENEActiv (activity bouts).

  11. 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)..

    Sleep measured by EEG and actigraphy (objective) as well as questionnaires (subjective)

Other outcomes

  1. Intervention tolerability

    Time frame: After the intervention week (one week after study inclusion).

    Measured using an intervention evaluation questionnaire (self-designed).

Study contacts

Contact information is provided by the study sponsor or research team.

Reto Huber, Prof.

CONTACT

[email protected]

0041442668160

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Collaborators

  • ETH Zurich
  • University of Zurich

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2021
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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