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Behavioral Intervention

Breathing Exercises for Concussion (Breathe Trial)

N/A

Recruiting

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of at least one post-concussion symptom in the Post-concussion Symptom Inventory (PSCI) that is relevant to autonomic nervous system (ANS) dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety, or sleep disturbances)

Aged 9-18 years

Must not have

History of previous neurological problems other than concussion

Known heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a breathing exercise program can help children and adolescents recover from a concussion. Participants will either do daily breathing exercises or receive regular care. They will be monitored weekly and assessed after

Who is the study for?

This trial is for children and adolescents who are in the sub-acute period after experiencing a concussion. They should be able to perform daily breathing exercises at home and participate in weekly phone check-ins. There's no mention of specific exclusion criteria, so it seems open to those meeting the inclusion requirements.

What is being tested?

The study tests if paced breathing exercises can help with autonomic function and reduce symptoms like anxiety, sleep issues, and severity of post-concussion symptoms compared to usual care. Participants will either do daily 10-minute breathing exercises or receive standard follow-up care.

What are the potential side effects?

Since this intervention involves non-invasive paced breathing exercises, significant side effects are not expected. However, there may be minor discomforts associated with any new exercise routine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience symptoms like dizziness, nausea, or sleep issues after a concussion.

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I am between 9 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had neurological issues other than a concussion.

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I have a known heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility-daily duration of practice

Feasibility-days of practice

Secondary study objectives

Autonomic nervous system function-Heart rate

Autonomic nervous system function-Heart rate variability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Breathing exercisesExperimental Treatment1 Intervention

In addition to the standard rehabilitation care in the concussion clinic, 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.

Group II: Usual careActive Control1 Intervention

Treatment for a concussion involves relative physical and cognitive rest for 24-48 hs, then a focus on gradually returning to normal activities and school as symptoms improve. Follow-up with healthcare professionals in the concussion clinic to ensure a safe and effective recovery and full return to school and sport. The concussion clinic follow-up includes meeting with a coordinator and physical therapist, and with a psychologist or MD if necessary

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Breathing exercises

2018

Completed Phase 2

~1390

0 / 4Eligibility criteria met