Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (NCT06559865)
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study
🩺 Plain-English Summary (8th-Grade Level)
The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention. Participants will: will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from a concussion follow-up program. A weekly phone meeting will be performed with the participants, to review exercise, providing, specific instructions, and making any necessary adjustments. All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.
Who can join: Review the eligibility criteria below.
Location: McGill University Health Center — Montreal, Quebec
Age range: 9 Years to 18 Years
🧪 Interventions in This Study
- Breathing exercises (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- McGill University Health Center — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (514) 412-4400
Email: isabelle.gagnon8@mcgill.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.