Auditory Slow Wave Enhancement After Concussion

NCT04770116 | Recruiting DMC

• 1 other identifier: 2020-00253
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Concussion Post Syndrome

Keywords

sleep; auditory stimulation; post-concussive symptoms; in-home EEG

Outcome Measures

Primary Outcomes (3)

• Cognitive Performance - attention

  Assessed by standardized test (normative values).

  Measured one month after study inclusion.

• Cognitive Performance - processing speed

  Assessed by standardized test (normative values).

  Measured one month after study inclusion.

• Cognitive Performance - executive function

  Assessed by standardized test (normative values).

  Measured one month after study inclusion.

Secondary Outcomes (11)

• Subjective recovery

  Measured at baseline, one week later (intermediate assessment), one month later (follow-up 1) and six months later (follow-up 2).

• Algorithm performance

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

• Neurological outcome

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

• Injury characteristics

  baseline, pre-intervention

• Other possible moderators of the Intervention

  Collected at the baseline assessment.

Other Outcomes (1)

• Intervention tolerability

  After the intervention week (one week after study inclusion).

Study Arms (2)

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).

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.

Device: Auditory Stimulation

Interventions

Auditory Stimulation DEVICE

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

Control group; Intervention group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• ETH Zurich: collaborator
• University of Zurich: collaborator

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Post-Concussion Syndrome

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Officials

• Reto Huber, Prof.

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reto Huber, Prof.

CONTACT

0041442668160; reto.huber@kispi.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study helpers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 25, 2021
• Study Start: May 31, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CH (1)