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NCT07082218
Following adolescent concussion, poor sleep health is common and relates to the development of persisting post-concussion symptoms, and uninjured adolescents (independent of concussion) also commonly experience sleep insufficiency. Given the sparse guidance that exists for clinicians to provide evidence-based sleep health recommendations for adolescents with a concussion, the primary objectives of this prospective randomized clinical trial of adolescents with a recent concussion are to discover if a multidimensional and prescriptive sleep health intervention leads to: 1) faster symptom resolution time, better sleep quality, or longer sleep duration; and 2) improved sleep habits, mental health, or academic engagement, relative to standard-of-care post-concussion sleep health guidance. Findings from this research will provide the basis for more precise sleep health recommendations for adolescents who experience a concussion.
NCT06644131
Objectives: Approximately one-third of patients with concussion experience persistent symptoms that, in addition to causing serious discomfort, may lead to unemployment and other socioeconomic challenges. Animal studies suggest that creatine monohydrate may alleviate post-concussive symptoms. This pilot study investigated the effects of creatine monohydrate on post-concussive symptoms in humans and assessed the feasibility of the pilot trial. Design: Three-arm randomised controlled pilot trial (intervention, placebo, control). Setting: Participants were recruited through neurological outpatient clinics and public outreach in Denmark. Participants: The study included 34 participants aged 20-45 years who had been experiencing persistent post-concussive symptoms for 6-18 months since injury. Participants were randomised to one of three groups. Intervention: The intervention group received 5 g of creatine monohydrate daily for seven weeks. The placebo group received an identical inert powder following the same regimen. The control group received usual care only. Primary and secondary outcome measures: The primary outcome was post-concussion symptoms (Rivermead Post Concussion Symptoms Questionnaire (RPQ)). Secondary outcomes were acute (RPQ-3) and persistent (RPQ-13) symptoms, assessed at three time points (week 0, 4 and 8). Results: All participants completed follow-up, indicating the trial's high feasibility and practicality. The intervention group did not significantly differ from the placebo or control groups. Moderate effect sizes were noted for RPQ-13 and total RPQ scores (d = -0.47, -0.46) and small for RPQ-3 scores (d = -0.22), although none reached statistical significance. Similar effects were observed between the placebo and control groups. Conclusions: The study showed strong usability and practical feasibility. Effect sizes were exploratory and not indicative as evidence of treatment efficacy at this stage. Larger randomized controlled trials are needed to determine whether creatine monohydrate could be a safe, accessible adjunctive treatment for post-concussive symptoms.
NCT07341880
This study aims to better understand how head impacts during ice hockey affect the brain and body, especially in young athletes. Even when players do not show clear signs of concussion, these repeated impacts may cause subtle changes in the brain's structure and in how the body regulates basic functions, such as heart rhythm and attention. This study will follow elite junior ice hockey players over the course of one full season to better understand the effects of repeated head impacts. Using a small helmet sensor (Bearmind) and video analysis, researchers will record and analyze every head impact that occurs during games and practices. Three times during the season - before, mid-season, and after - players will complete assessments of heart rate variability (using Polar H10 monitors) and a dual-task test that measures attention and coordination. After any diagnosed concussion, players will be reassessed with both heart rate variability and dual-task testing at 3 days post-injury. Following that, dual-task testing alone will be repeated every 3 days until return to sport. Players who experience a severe head impact, as detected by the helmet sensor, will also be evaluated 3 days after the impact with both heart rate variability and dual-task testing, even if no concussion symptoms are present. By combining these measures, the study aims to detect early physiological and cognitive changes following head impacts, improve understanding of sub-concussive effects, and support better prevention and management strategies for young athletes.