Heart Rate Variability Biofeedback in Older Adults

Brigham Young University (BYU)

Status and phase: Completed; Early Phase 1

Conditions: Older Adult

Treatments: Behavioral: OSC+; Behavioral: OSC-

Study type: Interventional

Funder types: Other

Identifiers

NCT05902286

HRVB_OA

Details and patient eligibility

About

Older adults will be randomly assigned to an active heart rate variability biofeedback condition and a "sham" control condition. Stress recovery measures and emotional and cognitive functioning will be assessed before and following the five-week intervention to assess potential changes from the intervention.

Full description

The goal of the current study is to compare heart rate variability biofeedback in an older adults study. The primary aims of the paper are to test whether there will be differences between HRV measurements pre- to post-intervention for HRV outcomes, stress recovery, and emotional and cognitive outcome measures. The investigators will implement an active HRVB condition and a control condition that utilizes methods developed by Yoo and colleagues. The "sham" control condition is designed to decrease the syncing of the baroreceptors and respiratory sinus arrhythmia and decrease heart rate oscillations. The target sample will be 50 older adults 65 years and older that will be randomized into the two groups.

Enrollment: 59 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fluent English speaker
• Able to provide informed consent
• 65 years or Older

Exclusion criteria

• Symptoms within the last year of a neurological disorder (e.g., dementia, stroke, epilepsy, traumatic brain injury with loss of consciousness in the last year, etc.).
• Conditions that might affect the biofeedback training (i.e., pacemakers, previous self-reported heart attack with hospitalization, self-reported coronary artery disease)
• Currently engaged in or have been previously trained in heart rate variability biofeedback.
• 3.3 or higher on the IQCODE.
• Currently prescribed and taking beta-blockers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups

OSC+

Experimental group

Description:

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.

Treatment:

Behavioral: OSC+

OSC-

Sham Comparator group

Description:

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.

Treatment:

Behavioral: OSC-