Older AdultEarly Phase 1NCT05902286
Heart Rate Variability Biofeedback in Older Adults
A Early Phase 1 study testing OSC+ and OSC- in people with Older Adult, run by Brigham Young University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adult
- What is being tested?
- OSC+ and OSC-
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 22 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Fluent English speaker
- Able to provide informed consent
- 65 years or Older
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study of Heart Rate Variability Biofeedback in an Older Adult Sample
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.
Read the detailed 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.
- Conditions
- Older Adult
- Being tested
- OSC+, OSC-
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSC+Behavioural
The first session of the HRVB intervention will focus on introducing the client to HRVB and calculating the participant's resonance frequency which typically range from 4.5-7 breaths per minute. Participants will first complete a five-minute baseline breathing condition. Following the breathing condition, the participants will complete five conditions for five minutes each. Specifically, each condition will have the person breath at 6, 6.5, 5.5, 5, and 4.5 breaths per minute with a minute break between. Session two will focus on practicing resonance frequency breathing and solidifying the correct resonance frequency for the participant. Additionally, this session will introduce the technique of breathing through pursed lips and abdominal breathing. For sessions three through five, participants will practice resonance frequency breathing and review previous strategies.
OSC-Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: OSC- |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 7 weeks.
Secondary outcomes (5)
Emotional Functioning: Satisfaction with Life Scale
One of the secondary aims is to evaluate whether change in HRV in older adults following HRVB are associated with subjective change in life satisfaction. To understand change in life satisfaction, researchers will have participants complete the Satisfaction with Life Scale during pre and post intervention testing sessions. The scale has a range of 5-35 with 5-9 representing extreme dissatisfaction with life and 31-35 with extremely satisfied with life.
Measured: Through study completion, an average of 7 weeks.
Emotional Functioning: Scale of Positive and Negative Emotions
As further evidence of potential changes in self-reported emotional functioning, all participants will complete the Scale of Positive and Negative Emotions. The scale results in a summed positive and negative score that ranges from 6 to 30 that will both be considered in analyses.
Measured: Through study completion, an average of 7 weeks.
Emotional Functioning: Geriatric Depression Scale-15
The researchers are interested in how self-reported depressive symptoms might change following intervention. To assess self-reported depression levels, all participants will be administered the Geriatric Depression Scale-15. The questionnaire scoring has four ranges reflecting depression severity: 0-4 (normal), 5-8 (mild); 9-11 (moderate); 12-15 (severe).
Measured: Through study completion, an average of 7 weeks.
Emotional Functioning: Depression and Stress Anxiety Scale
Lastly, to assess both self-reported depression and anxiety all participants will complete the Depression and Anxiety Stress Scale to examine potential changes following intervention. The questionnaire scoring has four separate ranges for depression, stress, and anxiety. Specifically, depression severity ranges included: 0-9 (normal), 10-13 (mild); 14-20 (moderate), 21-27 (severe), 28+ (extremely severe). Stress severity ranges included: 0-14 (normal), 15-18 (mild), 19-25 (moderate), 26-33 (severe), 34+ (extremely severe). Lastly, the anxiety ranges are 0-7 (normal), 8-9 (mild), 10-14 (moderate),15-19 (severe), 20+ (extremely severe).
Measured: Through study completion, an average of 7 weeks.
Cognitive Functioning
An additional aim of the study is to evaluate whether improvements in HRV in older adults following HRVB are associated with objective and subjective improvements in cognitive functioning (i.e., attention, inhibitory control). The investigators will be using the National Institute of Health (NIH) Toolkit to assess cognitive functioning.
Measured: Through study completion, an average of 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start17 Feb 2023
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham Young University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Whitney Allen, Brigham Young University
- Investigators
- Michael J Larson, Ph.D., Study chair, Brigham Young University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902286
- Sponsor's protocol ID
- HRVB_OA
- Status last verified
- Aug 2024
- First submitted
- 2 Apr 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, materials, and analysis plans are already posted on the Open Science Framework (https://osf.io/vse5n). Actual study data (de-identified) will be made available, along with analysis codes, once the study has been complete and published.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Heart Rate Variability Biofeedback in an Older Adult Sample
- ClinicalTrials.gov ID
- NCT05902286
- Acronym / sponsor ID
- HRVB_OA
- Conditions
- Older Adult
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Brigham Young UniversityUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| OSC+ | Experimental | Behavioral: OSC+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. |
| OSC- | Sham comparator | Behavioral: OSC-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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Fluent English speaker
- Able to provide informed consent
- 65 years or Older
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSC+The first session of the HRVB intervention will focus on introducing the client to HRVB and calculating the participant's resonance frequency which typically range from 4.5-7 breaths per minute. Participants will first complete a five-minute baseline breathing condition. Following the breathing condition, the participants will complete five conditions for five minutes each. Specifically, each condition will have the person breath at 6, 6.5, 5.5, 5, and 4.5 breaths per minute with a minute break between. Session two will focus on practicing resonance frequency breathing and solidifying the correct resonance frequency for the participant. Additionally, this session will introduce the technique of breathing through pursed lips and abdominal breathing. For sessions three through five, participants will practice resonance frequency breathing and review previous strategies. | Behavioural | OSC+ |
| OSC-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. | Behavioural | OSC- |
Primary outcome
Stress Recovery Change Following Intervention
Time frame: Through study completion, an average of 7 weeks.
The first primary aim of the paper is to test whether there will be difference resting HRV measurements pre- to post-intervention.
Resting HRV Change Following Intervention
Time frame: Through study completion, an average of 7 weeks.
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.
5 secondary outcomes
Emotional Functioning: Satisfaction with Life Scale
Time frame: Through study completion, an average of 7 weeks.
Emotional Functioning: Scale of Positive and Negative Emotions
Time frame: Through study completion, an average of 7 weeks.
Emotional Functioning: Geriatric Depression Scale-15
Time frame: Through study completion, an average of 7 weeks.
Emotional Functioning: Depression and Stress Anxiety Scale
Time frame: Through study completion, an average of 7 weeks.
Cognitive Functioning
Time frame: Through study completion, an average of 7 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Yes. Study protocol, materials, and analysis plans are already posted on the Open Science Framework (https://osf.io/vse5n). Actual study data (de-identified) will be made available, along with analysis codes, once the study has been complete and published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Larson, Ph.D. study chair
Brigham Young University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OSC+ and OSC- in people with Older Adult, run by Brigham Young University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Recovery Change Following Intervention (time frame: Through study completion, an average of 7 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.