Actively Recruiting

Phase Not Applicable
Age: 9Years - 18Years
All Genders
NCT07572734

Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)

Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-05-12

20

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 acute period after concussion. Secondary objectives include documenting symptom severity (ANS related symptoms, post-concussion symptoms, anxiety, sleep) before and after administration of the intervention and examine whether early paced-breathing exercise can accelerate recovery and symptom improvement. Participants 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 the Pediatric Emergency Department. A weekly phone meeting will be performed with all participants to assess recovery progress. Participants randomized to the intervention group will also be asked about their exercises, will be provided specific instructions and adjustments as necessary. 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.

CONDITIONS

Official Title

Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)

Who Can Participate

Age: 9Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 9-18 years old
  • Experienced a concussion within the past 72 hours
  • Presented to the emergency department with at least one post-concussion symptom related to autonomic nervous system dysfunction such as dizziness, nausea, fatigue, confusion, anxiety, or sleep disturbances
Not Eligible

You will not qualify if you...

  • Known heart disease
  • Previous neurological problems other than concussion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montreal Children's Hospital

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

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Research Team

I

Isabelle Gagnon, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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