Concussion Post SyndromeNCT04770116
Auditory Slow Wave Enhancement After Concussion
A study testing Auditory Stimulation in people with Concussion Post Syndrome, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion Post Syndrome
- What is being tested?
- Auditory Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 May 2021to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital Zurich
Zurich, 8032
Reto Huber
About this study
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
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.
Read the 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.
- Conditions
- Concussion Post Syndrome
- Being tested
- Auditory Stimulation
- Keywords
- sleep, auditory stimulation, post-concussive symptoms, in-home EEG
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory StimulationDevice
The device records biosignals and precisely plays tones to enhance sleep slow waves.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in this group will receive all-night auditory stimulation during sleep over one week using a portable, in-home device (MHSL-SleepBand). Receives: Device: Auditory Stimulation |
| Control group | Sham comparator | 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. Receives: Device: Auditory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance - attention
Assessed by standardized test (normative values).
Measured: Measured one month after study inclusion.
Cognitive Performance - processing speed
Assessed by standardized test (normative values).
Measured: Measured one month after study inclusion.
Cognitive Performance - executive function
Assessed by standardized test (normative values).
Measured: Measured one month after study inclusion.
Secondary outcomes (11)
Subjective recovery
Assessed by standardized symptom questionnaires.
Measured: Measured at baseline, one week later (intermediate assessment), one month later (follow-up 1) and six months later (follow-up 2).
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.
Measured: Recorded during seven nights of stimulation or sham (intervention week).
Neurological outcome
Measured using Magnetic Resonance Imaging (standard structural and hemodynamic imaging, DTI, and susceptibility weighting) to investigate the neurological outcome.
Measured: One month after study inclusion (follow-up 1).
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.
Measured: baseline, pre-intervention
Other possible moderators of the Intervention
For example age and socio-economic status.
Measured: Collected at the baseline assessment.
EEG power
Power in frequency bands (delta, theta, alpha, beta, gramma).
Measured: Recorded during the intervention week.
Sleep stages
EEG, EOG and EMG used for sleep scoring (sleep stages).
Measured: Recorded during the intervention week.
Sleep EEG characteristics
Characteristics of sleep EEG Features (slow waves, spindles).
Measured: Recorded during the intervention week.
Subjective sleep
Assessed by standardized questionnaire
Measured: 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)).
Actigraphy
Measured by GENEActiv (activity bouts).
Measured: Recorded during the intervention week.
Objective and subjective sleep measures
Sleep measured by EEG and actigraphy (objective) as well as questionnaires (subjective)
Measured: Recorded at all study visits over a period of six months (baseline assessment, intervention week, follow-up 1 and follow-up 2)..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start31 May 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion Post SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich, University of Zurich
- Responsible party
- Sponsor
- Investigators
- Reto Huber, Prof., Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770116
- Sponsor's protocol ID
- 2020-00253
- Status last verified
- Dec 2024
- First submitted
- 16 Feb 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04770116
- Acronym / sponsor ID
- 2020-00253
- Conditions
- Concussion Post Syndrome
- Keywords
- sleep, auditory stimulation, post-concussive symptoms, in-home EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich, University of Zurich
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Auditory StimulationParticipants in this group will receive all-night auditory stimulation during sleep over one week using a portable, in-home device (MHSL-SleepBand). |
| Control group | Sham comparator | Device: Auditory StimulationParticipants in this group will receive sham-stimulation, i.e. the device will be applied (biosignals will be recorded), but no tones will be played. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory StimulationThe device records biosignals and precisely plays tones to enhance sleep slow waves. | Device | Control group, Intervention group |
Primary outcome
Cognitive Performance - attention
Time frame: Measured one month after study inclusion.
Assessed by standardized test (normative values).
Cognitive Performance - processing speed
Time frame: Measured one month after study inclusion.
Assessed by standardized test (normative values).
Cognitive Performance - executive function
Time frame: Measured one month after study inclusion.
Assessed by standardized test (normative values).
11 secondary outcomes
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).
Algorithm performance
Time frame: Recorded during seven nights of stimulation or sham (intervention week).
Neurological outcome
Time frame: One month after study inclusion (follow-up 1).
Injury characteristics
Time frame: baseline, pre-intervention
Other possible moderators of the Intervention
Time frame: Collected at the baseline assessment.
EEG power
Time frame: Recorded during the intervention week.
Sleep stages
Time frame: Recorded during the intervention week.
Sleep EEG characteristics
Time frame: Recorded during the intervention week.
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)).
Actigraphy
Time frame: Recorded during the intervention week.
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)..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Related trials for Concussion Post Syndrome
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Not yet recruitingObservational study
Cognitive Effects of Hyperbaric Oxygen Therapy (HBOT) After a Traumatic Brain Injury
Traumatic Brain Injury, Post-Concussion Syndrome
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Traumatic Brain Injury
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reto Huber, Prof. principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Stimulation in people with Concussion Post Syndrome, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reto Huber, Prof. (0041442668160, reto.huber@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance - attention (time frame: Measured one month after study inclusion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.