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NCT Number: NCT07572734

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

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.

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Key information

Conditions

Concussion, Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paced breathing exercises

Behavioral

The paced breathing exercise including inhale for 4-second and exhale for 6-seconds, for a total of 6 breaths per minute.

Primary outcomes

  1. Feasibility-days of practice

    Time frame: 4 weeks

    Number of days children in the experimental group will engage in performing their breathing exercises

  2. Feasibility-daily duration of practice

    Time frame: 4 weeks

    Number of minutes children in the experimental group will engage in performing their breathing exercises

Secondary outcomes

  1. 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

  2. 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.

  3. 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. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Gagnon, PhD

CONTACT

[email protected]

514-412-4400 ext. 23896

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: Breathe - PED

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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