Recruiting

Paced Breathing

Sponsor:

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

Code:

NCT07572734

Conditions

Concussion, Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

Interventions

Paced breathing exercises

Study Details

Brief summary:

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

Concussion, Mild Traumatic Brain Injury

Study ID

NCT07572734

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Feasibility-days of practice [ Time Frame: 4 weeks ]
  • Feasibility-daily duration of practice [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

More Information

Sponsor

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

Last update posted

May 12, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-05-12.