Sickle Cell DiseaseNCT03383913
HRV-B for Symptom Management in Sickle Cell Patients
A study testing Heart Rate Variability Biofeedback in people with Sickle Cell Disease, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
This study will test the hypothesis that Heart Rate Variability Biofeedback (HRV-B) restores autonomic balance and reduces pain and other symptoms among patients with sickle cell disease (SCD).The specific aims of this study are to: (1) conduct a randomized, wait list controlled, pilot intervention trial to determine… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Heart Rate Variability Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 28 Dec 2018
- Phase
- Interventional
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- SCD patients
- 10 years old
- English literate
- Patient recruited through Greenville Health System
- Any race or ethnicity
- Any sex
Who cannot join
- Conditions affecting HRV (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina)
- Medications that affect cardiac rhythm (angiotensin converting enzyme, calcium channel, or beta-adrenergic inhibitors)
- Pacemaker or defibrillator
- Heart transplant or by-pass surgery within 1 year
- Active seizure disorder or use of antiseizure/anticonvulsant medication specifically for seizures
- Dementia
Show all 11Show fewer
- Moderate or severe head injury or stroke within 6 months
- Evidence of active substance abuse
- An uncontrolled major psychiatric disorder
- Cognitive disability that precludes participation
- Use of long acting (extended release) opioid medications; however, 'as needed' short acting opioid medication usage is allowable
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Integrative Oncology and Survivorship
Greenville, South Carolina, 29605
About this study
Official title: Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Sickle Cell Patients: Pilot Intervention
This study will test the hypothesis that Heart Rate Variability Biofeedback (HRV-B) restores autonomic balance and reduces pain and other symptoms among patients with sickle cell disease (SCD).The specific aims of this study are to: (1) conduct a randomized, wait list controlled, pilot intervention trial to determine whether HRV-B increases HRV coherence among SCD participants (minimum N of 30, up to 50 total); (2) determine whether HRV-B reduces pain, stress, fatigue, depression or insomnia among SCD participants; and (3) determine whether increases in HRV coherence are associated improvements in pain, stress, fatigue, depression, or sleep among study participants.
Read the detailed description
The purpose of this study is to see if Heart Rate Variability Biofeedback (HRV-B) can reduce chronic pain, stress, depression, anxiety, insomnia, loneliness, helplessness, physical limitations and pain medication dependence. HRV-B is an interactive procedure in which participants relax and breathe regularly while watching a computer screen. The computer screen provides feedback that helps people increase their heart rate variability, which is the difference from beat to beat. HRV-B is a complementary, non-pharmacologic therapy that is now being used to see if it can help sickle cell patients reduce their symptoms of pain, stress, insomnia, fatigue, or depression.
Participants will be randomly assigned to either an Intervention Group or a Comparison Group. Each group will have about 15-20 participants. The Intervention group will receive a baseline assessment including symptom questionnaires, up to six weekly HRV-B training sessions lasting about 45 minutes each, and a follow-up assessment including symptom questionnaires. There are 6-8 total visits for the intervention group and 2 for the control group. The Comparison Group will have a baseline assessment including symptom questionnaires, then six weeks with no training sessions, then a follow up assessment including symptom questionnaires. After the follow up assessment, the Comparison Group members will have the option of receiving the same treatment as the Intervention Group.
- Conditions
- Sickle Cell Disease
- Being tested
- Heart Rate Variability Biofeedback
- Keywords
- Heart Rate Variability Biofeedback, Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Variability BiofeedbackBehavioural
Over a period of 4-6 weeks participants in the intervention arm will learn a series of breathing techniques to determine Heart Rate Variability's effects on physical function, anxiety, depression, fatigue, sleep disturbance, participation in social activities, pain interference and intensity.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm baseline visit will include: Institutional Review Board (IRB) consent, PROMIS measure baseline and outcome assessments, instructions on placement of Firstbeat device and use of Firsbeat journal, resting HRV recording using Firsbeat software for 15 minutes, saliva collection, and distribution of actigraph watch to quantify sleep quality. Participants placed in the intervention arm will receive 4-6 weeks of Heart Rate Variability Biofeedback training. All measures will be repeated at the end of the six week period. Receives: Behavioral: Heart Rate Variability Biofeedback |
| Control | No intervention | The control arm baseline visit will include: Institutional Review Board (IRB) consent, PROMIS measure assessments, instructions on placement of Firstbeat device and use of Firsbeat journal, resting HRV recording using Firstbeat software for 15 minutes, saliva collection, and distribution of actigraph watch to quantify sleep quality. The control group will receive their usual care for SCD and complete baseline and post-baseline outcome assessments without any HRV-B training. All measures will be repeated at the end of the six week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Measurement Information System (PROMIS) Measures
A comprehensive survey of physical function, anxiety, sleep disturbance, depression, fatigue, social roles, pain interference, and pain intensity are completed before the study begins and upon completion. Each domain is measured with a separate short form consisting of eight questions, with the exception of pain intensity, which is measured as a raw score of zero to ten. The scores of these surveys are combined. This number is then converted to a single PROMIS measure T score metric.
Measured: 4-6 weeks
Secondary outcomes (2)
Sleep Quality
Sleep quality will be quantified using wrist actigraph monitors that will be worn by the subject for seven days at the beginning and end of the study
Measured: 4-6 weeks
C-Reactive Protein in saliva
Protein saliva samples will be collected by participants at baseline and at followup. Using an ELISA assay kit we will quantify inflammation mediators and C-Reactive Protein.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start22 Jan 2018
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Aniket Saha, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383913
- Sponsor's protocol ID
- Pro00066320
- Status last verified
- Oct 2024
- First submitted
- 18 Jul 2017
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Sickle Cell Patients: Pilot Intervention
- ClinicalTrials.gov ID
- NCT03383913
- Acronym / sponsor ID
- Pro00066320
- Conditions
- Sickle Cell Disease
- Keywords
- Heart Rate Variability Biofeedback, Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- University of South Carolina
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 27 Dec 2017 (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.
This study will test the hypothesis that Heart Rate Variability Biofeedback (HRV-B) restores autonomic balance and reduces pain and other symptoms among patients with sickle cell disease (SCD).The specific aims of this study are to: (1) conduct a randomized, wait list controlled, pilot intervention trial to determine whether HRV-B increases HRV coherence among SCD participants (minimum N of 30, up to 50 total); (2) determine whether HRV-B reduces pain, stress, fatigue, depression or insomnia among SCD participants; and (3) determine whether increases in HRV coherence are associated improvements in pain, stress, fatigue, depression, or sleep among study participants.
Detailed description
The purpose of this study is to see if Heart Rate Variability Biofeedback (HRV-B) can reduce chronic pain, stress, depression, anxiety, insomnia, loneliness, helplessness, physical limitations and pain medication dependence. HRV-B is an interactive procedure in which participants relax and breathe regularly while watching a computer screen. The computer screen provides feedback that helps people increase their heart rate variability, which is the difference from beat to beat. HRV-B is a complementary, non-pharmacologic therapy that is now being used to see if it can help sickle cell patients reduce their symptoms of pain, stress, insomnia, fatigue, or depression.
Participants will be randomly assigned to either an Intervention Group or a Comparison Group. Each group will have about 15-20 participants. The Intervention group will receive a baseline assessment including symptom questionnaires, up to six weekly HRV-B training sessions lasting about 45 minutes each, and a follow-up assessment including symptom questionnaires. There are 6-8 total visits for the intervention group and 2 for the control group. The Comparison Group will have a baseline assessment including symptom questionnaires, then six weeks with no training sessions, then a follow up assessment including symptom questionnaires. After the follow up assessment, the Comparison Group members will have the option of receiving the same treatment as the Intervention Group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Heart Rate Variability BiofeedbackThe intervention arm baseline visit will include: Institutional Review Board (IRB) consent, PROMIS measure baseline and outcome assessments, instructions on placement of Firstbeat device and use of Firsbeat journal, resting HRV recording using Firsbeat software for 15 minutes, saliva collection, and distribution of actigraph watch to quantify sleep quality. Participants placed in the intervention arm will receive 4-6 weeks of Heart Rate Variability Biofeedback training. All measures will be repeated at the end of the six week period. |
| Control | No intervention | –The control arm baseline visit will include: Institutional Review Board (IRB) consent, PROMIS measure assessments, instructions on placement of Firstbeat device and use of Firsbeat journal, resting HRV recording using Firstbeat software for 15 minutes, saliva collection, and distribution of actigraph watch to quantify sleep quality. The control group will receive their usual care for SCD and complete baseline and post-baseline outcome assessments without any HRV-B training. All measures will be repeated at the end of the six week period. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- SCD patients
- 10 years old
- English literate
- Patient recruited through Greenville Health System
- Any race or ethnicity
Key exclusion criteria (11 listed)
- Conditions affecting HRV (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina)
- Medications that affect cardiac rhythm (angiotensin converting enzyme, calcium channel, or beta-adrenergic inhibitors)
- Pacemaker or defibrillator
- Heart transplant or by-pass surgery within 1 year
- Active seizure disorder or use of antiseizure/anticonvulsant medication specifically for seizures
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 |
|---|---|---|
| Heart Rate Variability BiofeedbackOver a period of 4-6 weeks participants in the intervention arm will learn a series of breathing techniques to determine Heart Rate Variability's effects on physical function, anxiety, depression, fatigue, sleep disturbance, participation in social activities, pain interference and intensity. | Behavioural | Intervention |
Primary outcome
Patient Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: 4-6 weeks
A comprehensive survey of physical function, anxiety, sleep disturbance, depression, fatigue, social roles, pain interference, and pain intensity are completed before the study begins and upon completion. Each domain is measured with a separate short form consisting of eight questions, with the exception of pain intensity, which is measured as a raw score of zero to ten. The scores of these surveys are combined. This number is then converted to a single PROMIS measure T score metric.
2 secondary outcomes
Sleep Quality
Time frame: 4-6 weeks
C-Reactive Protein in saliva
Time frame: 4-6 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 28 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Aniket Saha, MD principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Rate Variability Biofeedback in people with Sickle Cell Disease, run by Prisma Health-Upstate 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 6 inclusion and 11 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 28 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Patient Reported Outcomes Measurement Information System (PROMIS) Measures (time frame: 4-6 weeks). 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 28 Oct 2024.