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Biofeedback

Heart Rate Variability Biofeedback for Aging Adults

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
Be older than 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 will test a 5-week heart rate variability biofeedback program to reduce stress in older adults, and measure if it affects their emotions & thinking.

Who is the study for?
This trial is for older adults who are at least 65 years old, can speak English fluently, and are able to give informed consent. It's not suitable for those on beta-blockers, with past heart rate variability biofeedback training, certain neurological disorders in the last year, or conditions like pacemakers that could interfere with biofeedback.Check my eligibility
What is being tested?
The study tests a heart rate variability biofeedback intervention (OSC+) against a sham control (OSC-) in aging adults. Over five weeks, participants' stress recovery and emotional and cognitive functions will be evaluated to see if there's any improvement from the treatment.See study design
What are the potential side effects?
Since this trial involves non-invasive biofeedback rather than medication or surgery, side effects may be minimal but could include discomfort due to sitting still during sessions or frustration if difficulties in following the procedure occur.

Timeline

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 Change Following Intervention
Stress Recovery Change Following Intervention
Secondary outcome measures
Cognitive Functioning
Emotional Functioning: Depression and Stress Anxiety Scale
Emotional Functioning: Geriatric Depression Scale-15
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OSC+Experimental Treatment1 Intervention
The 25 participants assigned to the OSC+ condition will complete a five-week intervention for the Osc+ portion of the study using emWave software for biofeedback. There will be one 30-60 minute in-person HRVB session once a week completed at the University Parkway Center. In addition to the in-person session, the participant will complete four 20-minute homework sessions during the following week. The format of five weeks of one weekly session and four homework sessions is effective at helping participants learn and implement breathing and biofeedback skills. The five HRVB session will be based on the Lehrer and colleagues' protocol.
Group II: OSC-Placebo Group1 Intervention
Similarly, for the Osc- procedures, the client will be required to complete a five-week intervention. 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 that gives feedback regarding a "calmness" score which reflects a better score (i.e., higher) when participants breathe in a pattern that elicits less variability (i.e., less oscillations). They will be asked to complete four 20-minute homework assignments at home and asked to come up with techniques to decrease their heart rate.

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Who is running the clinical trial?

Brigham Young UniversityLead Sponsor
22 Previous Clinical Trials
10,152 Total Patients Enrolled
Michael J Larson, Ph.D.Study ChairBrigham Young University

Media Library

OSC+ (Biofeedback) Clinical Trial Eligibility Overview. Trial Name: NCT05902286 — Phase < 1
Aging Adults Research Study Groups: OSC-, OSC+
Aging Adults Clinical Trial 2023: OSC+ Highlights & Side Effects. Trial Name: NCT05902286 — Phase < 1
OSC+ (Biofeedback) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05902286 — 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 open enrollment window for this investigation?

"As per the details available on clinicaltrials.gov, this medical trial is currently seeking enrollees. It was initially made public on February 17th 2023 and last updated June 12th 2023."

Answered by AI

What is the current enrollment of this research experiment?

"Correct. Clinicaltrials.gov confirms that this ongoing medical trial, which was initially posted on February 17th 2023, is still recruiting participants. 50 patients must be sourced from a single centre for the study to proceed as planned."

Answered by AI

What objectives are investigators trying to accomplish with this research?

"The primary outcome that will be measured throughout this medical trial is the difference in resting HRV following intervention. Secondary objectives include evaluating changes to self-reported emotional functioning by using the Scale of Positive and Negative Emotions (with scores ranging from 6 to 30) as well as Geriatric Depression Scale-15 (ranging from 0-4, 5-8, 9-11 or 12-15). Lastly, cognitive function will also be assessed through NIH Toolkit over an average time frame of 7 weeks."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Heart Rate Variability Biofeedback in Older Adults
Whitney Allen 2023. "Heart Rate Variability Biofeedback in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05902286.
~22 spots leftby May 2025
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