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Behavioral Intervention

Heart Rate Variability Biofeedback for Traumatic Brain Injury

Q: Is there an age limit for participants in this experiment?

In order to be accepted into this medical trial, individuals must meet the age criteria of 18 and below 55 years old.

Q: Are there still open slots for participation in this experiment?

Affirmative, clinicaltrials.gov displays that this trial is presently enrolling participants as of June 12th 2023 - originally published on February 15th 2023. Specifically, the research team seeks 50 subjects from a single site.

Q: Who is eligible to enrol in this clinical experiment?

Aspiring participants of this trial need to meet the criteria of having sustained a <a href="https://www.withpower.com/clinical-trials/traumatic-brain-injury">traumatic brain injury</a> and be within an age range between 18-55 years old. This clinical investigation has space for up to 50 people.

Q: How many people are enrolled in this research endeavor?

Affirmative. According to clinicaltrials.gov, this research endeavour was initially listed on February 15th of 2023 and is currently recruiting participants. The study requires 50 volunteers from a single medical centre.

Q: What is the foremost purpose of this research endeavor?

The main desired outcome of this trial, which will take an average of 7 weeks to complete, is the measurement of Resting HRV. Secondary goals include assessing participants' experiences through the Scale of Positive and Negative Experience (a 12-item scale that uses a 5-point scale from 1 [never] to 5 [always]), <a href="https://www.withpower.com/clinical-trials/depression">Depression</a> <a href="https://www.withpower.com/clinical-trials/anxiety">Anxiety</a> Stress Scales (with 42 items related to negative emotions on a 4-point frequency/severity rating system), and Satisfaction with Life Scale (5 questions scored on a 7 point scale).

Phase < 1

Recruiting

Research Sponsored by Brigham Young University

Eligibility Criteria Checklist

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

Must have

Aged 18-55 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 7 weeks

Awards & highlights

Study Summary

This trial is testing the effect of heart rate variability biofeedback on mild brain injury. Participants will be randomly assigned to two conditions, one designed to increase heart rate oscillations and one that decreases them.

Who is the study for?

This trial is for individuals aged 18-55 who have had a mild traumatic brain injury at least six months ago, speak English fluently, and can consent to participate. It's not for those with pacemakers, past severe heart attacks, learning disabilities, other neurological issues like stroke or epilepsy, involvement in litigation related to their injury, or uncorrected vision problems.Check my eligibility

What is being tested?

The study compares two types of heart rate variability biofeedback treatments for people with traumatic brain injury: one that aims to increase heart rate oscillations (OSC+) and another that decreases them (OSC-). Participants will be randomly placed into either the active treatment or sham condition over five weeks.See study design

What are the potential side effects?

Since this trial involves non-invasive biofeedback therapy rather than medication or surgery, side effects are minimal but may include discomfort from wearing the device used to monitor heart rate variability.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 7 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Resting HRV

Stress Recovery

Secondary outcome measures

Cognitive Functioning

Depression Anxiety Stress Scales

Physical Symptoms

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OSC+Experimental Treatment1 Intervention

Twenty-five participants will complete five weeks of heart rate variability biofeedback using emWave software (HeartMath®Institute, 2020). Participants will receive a weekly 30-minute heart rate variability biofeedback session for five weeks at the University Parkway Center, Brigham Young University. The heart rate variability biofeedback protocol will be based on Lehrer et al., 2013 and Yoo et al., 2022. This format will aid participants in implementing and learning breathing and heart rate variability biofeedback skills (Lehrer et al., 2020). All participants will wear an ear sensor to measure their pulse. The heart rate variability biofeedback will focus on autonomic balance through slow breathing at a resonance frequency of approximately 6 breathes per minute. The best approximate breathing pace for resonance frequency will be estimated and participant's resonance frequency will be provided and used for their homework and subsequent training sessions.

Group II: OSC-Placebo Group1 Intervention

Twenty-five participants will complete five weeks of Osc-. Similarly, for the Osc- procedures, the client will be required to complete a five-week intervention. During the weekly session, participants will also be wearing an earlobe monitor with HeartMath. Participants will be administered the Scale of Positive and Negative Experience at the beginning of each session to assess for mood. Participants will also be administered the 3-item Rivermead Post Concussion Symptoms Questionnaire at the beginning of each session. Participants will be instructed that the purpose of this portion of the study is to decrease their breathing oscillations. A program was designed by Yoo and colleagues (2022) that gives feedback regarding a "calmness" score which reflects a better score (i.e., higher) when participants breath in a pattern that elicits less variability (i.e., less oscillations).

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Brigham Young UniversityLead Sponsor

22 Previous Clinical Trials

10,172 Total Patients Enrolled

Michael J Larson, PhDStudy ChairBrigham Young University

Media Library

OSC- (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05913505 — Phase < 1

Traumatic Brain Injury Research Study Groups: OSC+, OSC-

Traumatic Brain Injury Clinical Trial 2023: OSC- Highlights & Side Effects. Trial Name: NCT05913505 — Phase < 1

OSC- (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05913505 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for participants in this experiment?

"In order to be accepted into this medical trial, individuals must meet the age criteria of 18 and below 55 years old."

Answered by AI

Are there still open slots for participation in this experiment?

"Affirmative, clinicaltrials.gov displays that this trial is presently enrolling participants as of June 12th 2023 - originally published on February 15th 2023. Specifically, the research team seeks 50 subjects from a single site."

Answered by AI

Who is eligible to enrol in this clinical experiment?

"Aspiring participants of this trial need to meet the criteria of having sustained a traumatic brain injury and be within an age range between 18-55 years old. This clinical investigation has space for up to 50 people."

Answered by AI

How many people are enrolled in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this research endeavour was initially listed on February 15th of 2023 and is currently recruiting participants. The study requires 50 volunteers from a single medical centre."

Answered by AI

What is the foremost purpose of this research endeavor?

"The main desired outcome of this trial, which will take an average of 7 weeks to complete, is the measurement of Resting HRV. Secondary goals include assessing participants' experiences through the Scale of Positive and Negative Experience (a 12-item scale that uses a 5-point scale from 1 [never] to 5 [always]), Depression Anxiety Stress Scales (with 42 items related to negative emotions on a 4-point frequency/severity rating system), and Satisfaction with Life Scale (5 questions scored on a 7 point scale)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Heart Rate Variability Biofeedback Following Traumatic Brain Injury

Leah Talbert 2023. "Heart Rate Variability Biofeedback Following Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05913505.

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