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

May 7, 2026 updated by: Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre

Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 9-18 years old
  • 0-72 hours post-concussion
  • present to the ED with at least one post-concussion symptom in the Post-concussion Symptom Inventory (PSCI) that is relevant to ANS dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety or sleep disturbances)

Exclusion Criteria:

  • known heart disease,
  • previous neurological problems other than concussion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Breathing exercises
In addition to the standard care in the Pediatric Emergency Department, the intervention group will have a daily 10-minutes paced breathing home-exercise program. The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.
Behavioral: Paced breathing exercises
The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.
No Intervention: Usual Care
Treatment for a concussion involves relative physical and cognitive rest for 24-48 hours, followed by gradually returning to normal activities and school as symptoms improve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility-days of practice
Time Frame: 4 weeks
Number of days children in the experimental group will engage in performing their breathing exercises
4 weeks
Feasibility-daily duration of practice
Time Frame: 4 weeks
Number of minutes children in the experimental group will engage in performing their breathing exercises
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Document autonomic nervous system related symptoms before and after administration of the intervention using the modified Composite Autonomic Symptom Score 31 (COMPASS-31) questionnaire.
Time Frame: 4 weeks
The COMPASS-31 is a self-reported questionnaire that investigates the presence of 31 symptoms in six ANS domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor. Respondents report symptoms on a dichotomous (yes/no) and on Likert- like scales to indicate aspects such as frequency, severity, and changes in the symptoms. The subscales are then scored according to a weighted formula, and sum to a total COMPASS-31 score out of 100 where higher scores indicate more severe ANS symptoms
4 weeks
Document changes in anxiety before and after administration of the intervention using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Pediatric Anxiety- Short Form 8a
Time Frame: 4 weeks
PROMIS anxiety assesses emotional, cognitive, and physical symptoms of anxiety in children and adolescents; higher scores indicate greater impairment where scores of 8-15 indicate minimal anxiety symptoms, 16-21 indicate mild anxiety symptoms, 22-32 indicate moderate anxiety symptoms, 33-40 severe anxiety symptoms.
4 weeks
Document changes in sleep before and after administration of the intervention using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Pediatric Sleep-Related Impairment and Sleep Disturbance- Short Forms 4a.
Time Frame: 4 weeks
PROMIS sleep questionnaires are scored by summing responses to 4 questions, scores ranging from 4 to 20. Raw scores are converted to a standardized T-score via conversion tables, with higher t-scores indicating worse sleep quality.
4 weeks
Document post-concussion symptoms before and after administration of the intervention using the Post-Concussion Symptom Inventory for Children (PSCI-C) questionnaire.
Time Frame: 4 weeks
The PCSI-C is a symptom scale with age-based versions. For the purpose of this study 2 age-based versions will be used, 8-12 and 13-18. The ages 8-12 version is a 17-items, 3-point Guttman Scale (0-2), and the ages 13-18, is a 20-items, 7-point Guttman Scale (0-6). Participants are asked to rate their current PCS in reference to the day of assessment and/or the previous day and retrospectively rate their symptoms prior to injury. The total PCS change score (current PCS minus retrospective pre-injury symptoms; delta PCSI-P) will be used, with higher scores (range: 0-120) indicating more severe symptomatology.
4 weeks
Examine whether early paced-breathing exercise can accelerate recovery and symptom improvement (ANS-related symptoms, PCS, sleep and anxiety), and reduce the risk of persistent post-concussive symptoms.
Time Frame: 4 weeks
Recovery- differences between groups in the time to fully return to school, return to sport and medication clearance. Symptoms improvement- measures described above will be compared within each group and between groups. Reduce the risk of persistent post-concussive symptoms- measures described above will be compared within each group and between groups in addition to the number of treatments and/or the need for specialized concussion care.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

May 1, 2026

First Submitted That Met QC Criteria

May 1, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-10503-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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