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HRV-B for Symptom Management in Sickle Cell Patients

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ClinicalTrials.gov Identifier: NCT03383913
Recruitment Status : Enrolling by invitation
First Posted : December 27, 2017
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
University of South Carolina
Information provided by (Responsible Party):
Greenville Health System

Brief 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 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Heart Rate Variability Biofeedback Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Heart Rate Variability (HRV) Biofeedback for Symptom Management Among Sickle Cell Patients: Pilot Intervention
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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.
Behavioral: Heart Rate Variability Biofeedback
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.

No Intervention: Control
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sleep Quality [ Time Frame: 4-6 weeks ]
    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

  2. C-Reactive Protein in saliva [ Time Frame: 4-6 weeks ]
    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.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SCD patients
  • 10 years old
  • English literate
  • Patient recruited through Greenville Health System
  • Any race or ethnicity
  • Any sex

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383913


Locations
United States, South Carolina
Center for Integrative Oncology and Survivorship
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Greenville Health System
University of South Carolina
Investigators
Principal Investigator: Aniket Saha, MD Greenville Health System

Responsible Party: Greenville Health System
ClinicalTrials.gov Identifier: NCT03383913     History of Changes
Other Study ID Numbers: Pro00066320
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Greenville Health System:
Heart Rate Variability Biofeedback
Sickle Cell Disease

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn