- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04770116
Auditory Slow Wave Enhancement After Concussion
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reto Huber, Prof.
- Phone Number: 0041442668160
- Email: reto.huber@kispi.uzh.ch
Study Locations
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Zurich, Switzerland, 8032
- Recruiting
- University Children's Hospital Zurich
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Contact:
- Reto Huber
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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).
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The device records biosignals and precisely plays tones to enhance sleep slow waves.
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Sham Comparator: 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.
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The device records biosignals and precisely plays tones to enhance sleep slow waves.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Performance - attention
Time Frame: Measured one month after study inclusion.
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Assessed by standardized test (normative values).
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Measured one month after study inclusion.
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Cognitive Performance - processing speed
Time Frame: Measured one month after study inclusion.
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Assessed by standardized test (normative values).
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Measured one month after study inclusion.
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Cognitive Performance - executive function
Time Frame: Measured one month after study inclusion.
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Assessed by standardized test (normative values).
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Measured one month after study inclusion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Assessed by standardized symptom questionnaires.
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Measured at baseline, one week later (intermediate assessment), one month later (follow-up 1) and six months later (follow-up 2).
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Algorithm performance
Time Frame: Recorded during seven nights of stimulation or sham (intervention week).
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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.
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Recorded during seven nights of stimulation or sham (intervention week).
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Neurological outcome
Time Frame: One month after study inclusion (follow-up 1).
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Measured using Magnetic Resonance Imaging (standard structural and hemodynamic imaging, DTI, and susceptibility weighting) to investigate the neurological outcome.
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One month after study inclusion (follow-up 1).
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Injury characteristics
Time Frame: baseline, pre-intervention
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Only for patients: Injury characteristics collected from the Hospital Information System that might influence baseline and follow-up measures and their change over time.
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baseline, pre-intervention
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Other possible moderators of the Intervention
Time Frame: Collected at the baseline assessment.
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For example age and socio-economic status.
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Collected at the baseline assessment.
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EEG power
Time Frame: Recorded during the intervention week.
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Power in frequency bands (delta, theta, alpha, beta, gramma).
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Recorded during the intervention week.
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Sleep stages
Time Frame: Recorded during the intervention week.
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EEG, EOG and EMG used for sleep scoring (sleep stages).
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Recorded during the intervention week.
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Sleep EEG characteristics
Time Frame: Recorded during the intervention week.
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Characteristics of sleep EEG Features (slow waves, spindles).
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Recorded during the intervention week.
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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)).
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Assessed by standardized questionnaire
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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)).
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Actigraphy
Time Frame: Recorded during the intervention week.
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Measured by GENEActiv (activity bouts).
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Recorded during the intervention week.
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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)..
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Sleep measured by EEG and actigraphy (objective) as well as questionnaires (subjective)
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Recorded at all study visits over a period of six months (baseline assessment, intervention week, follow-up 1 and follow-up 2)..
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention tolerability
Time Frame: After the intervention week (one week after study inclusion).
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Measured using an intervention evaluation questionnaire (self-designed).
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After the intervention week (one week after study inclusion).
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Collaborators and Investigators
Investigators
- Principal Investigator: Reto Huber, Prof., University Children's Hospital, Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-00253
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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