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Auditory Slow Wave Enhancement After Concussion

NCT ID: NCT04770116

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Concussion Post Syndrome

Keywords

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sleep auditory stimulation post-concussive symptoms in-home EEG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Study helpers

Study Groups

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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).

Group Type EXPERIMENTAL

Auditory Stimulation

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Auditory Stimulation

Intervention Type DEVICE

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

Interventions

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Auditory Stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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)


* 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.

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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ETH Zurich

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reto Huber, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

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University Children's Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Reto Huber, Prof.

Role: CONTACT

Phone: 0041442668160

Email: [email protected]

Facility Contacts

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Reto Huber

Role: primary

Other Identifiers

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2020-00253

Identifier Type: -

Identifier Source: org_study_id