Last reviewed · How we verify

NCT04770116

Auditory Slow Wave Enhancement After Concussion

Recruiting now NA Last updated 9 December 2024
What this trial tests

NA trial testing Auditory Stimulation in Concussion Post Syndrome in 120 participants. Currently enrolling.

Timeline
31 May 2021
Primary endpoint
31 March 2026
31 March 2026

Quick facts

Lead sponsorUniversity Children's Hospital, Zurich
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment120
Start date31 May 2021
Primary completion31 March 2026
Estimated completion31 March 2026
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University Children's Hospital, Zurich

Who can join

Adults 6 to 18, any sex, with Concussion Post Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Auditory Stimulation

Trials testing the same drug.

Other University Children's Hospital, Zurich trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04770116.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing