Heart Rate Variability Biofeedback in Older Adults

NCT05902286 | Completed Early Phase 1

• 1 other identifier: HRVB_OA
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older Adult

Outcome Measures

Primary Outcomes (2)

• Stress Recovery Change Following Intervention

  The first primary aim of the paper is to test whether there will be difference resting HRV measurements pre- to post-intervention.

  Through study completion, an average of 7 weeks.

• Resting HRV Change Following Intervention

  The second primary aim of the study will be to test the utility of HRVB compared to sham control in improving HRV following a stressor in older adults using a randomized trial design.

  Through study completion, an average of 7 weeks.

Secondary Outcomes (5)

• Emotional Functioning: Satisfaction with Life Scale

  Through study completion, an average of 7 weeks.

• Emotional Functioning: Scale of Positive and Negative Emotions

  Through study completion, an average of 7 weeks.

• Emotional Functioning: Geriatric Depression Scale-15

  Through study completion, an average of 7 weeks.

• Emotional Functioning: Depression and Stress Anxiety Scale

  Through study completion, an average of 7 weeks.

• Cognitive Functioning

  Through study completion, an average of 7 weeks.

Study Arms (2)

OSC+

EXPERIMENTAL

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.

Behavioral: OSC+

OSC-

SHAM COMPARATOR

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.

Behavioral: OSC-

Interventions

OSC- BEHAVIORAL

During the first week, the baseline will be assessed and resonance frequency. Specifically, during their first intervention session the participants will be told that the goal of the sessions includes decreasing heart rate variability and avoiding slow and steady breathing. The participants will then be asked to choose five strategies to lower their heart rate oscillations. Participants will be told to avoid slow breathing as it causes large heart rate oscillations. For the second session, the therapist will check in with the participant and discuss how the practice went. Participants will then select three strategies that they will practice for three five-minute conditions following a five-minute baseline. Sessions three, four, and five will include three conditions: a five-minute baseline and two strategies of their choice. For each session, the best strategy will be calculated and written on the assignment sheets to be used during the week for their four homework sessions.

OSC-

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• or higher on the IQCODE.
• Currently prescribed and taking beta-blockers.

Sponsors & Collaborators

• Brigham Young University: lead

Study Sites (1)

Brigham Young Unversity

Provo, Utah, 84604, United States

Location

Study Officials

• Michael J Larson, Ph.D.

  Brigham Young University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The testing sessions will be completed by research assistants who are blinded to the participant's condition as not to influence testing results. All participants will be randomized into a condition (e.g., Osc+ or Osc-) by a graduate student so research assistants doing the assessments are blinded to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The investigators plan to collect a sample of 50 older adult participants (25 per group) for the current study. Participants who meet the inclusion and exclusion criteria will then be randomized into the Osc+ or Osc- group for the five-week condition. All randomization in this study will be completed using a quasi-random number generator constrained so there are equal numbers of participants in each condition.

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: June 13, 2023
• Study Start: February 17, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Once data collection and data analysis has been completed and published in a scientific journal, the study data (de-identified) will either be posted on an open science website, such as the Open Science Framework, or will be given to other researchers upon request.

Locations

US (1)