None listed
Conditions
Brief summary
We aim to investigate the effect of Heart Rate Variability Biofeedback on FGIDs. We hypothesise that frequent training with HRVB will result in improved BSGM scores primarily. As secondary outcomes we will measure the change in their gastrointestinal symptoms, autonomic function and psychological well-being. As this is a physiological study, we aim here to demonstrate feasibility and adherence to therapy, as well as trends in clinical efficacy that could be used to power a future RCT.
Interventions
This trial is made up of 1 initial clinic visit, 6 weeks of at-home biofeedback training and then a follow-up clinic visit at 6 weeks. The initial clinic visit will last 6 hours (including an optional comfort break) and the follow-up visit will last 4 and a half hours. Both of these will occur at the Alimetry clinic and will be conducted by a trained researcher.
During the first clinic visit of this trial participants will first have a baseline Body-Surface Gastric Mapping test (BSGM) and then
This trial is made up of 1 initial clinic visit, 6 weeks of at-home biofeedback training and then a follow-up clinic visit at 6 weeks. The initial clinic visit will last 6 hours (including an optional comfort break) and the follow-up visit will last 4 and a half hours. Both of these will occur at the Alimetry clinic and will be conducted by a trained researcher. During the first clinic visit of this trial participants will first have a baseline Body-Surface Gastric Mapping test (BSGM) and then be trained to conduct heart rate variability biofeedback at their resonant frequency. A single lead Electrocardiogram (ECG), peripheral temperature probe, finger photoplethysmography (PPG), and skin conductance electrodes will be placed on the participant's hands, along with a respiration belt. The participant will then be instructed to breathe at different breathing rates, between 5-7 breaths/min, in order to find the breathing frequency that will result in the most optimal heart rate variaibility (HRV) response. This breathing rate will be the participant's resonant frequency at which they will breathe for all future biofeedback sessions. During this and all biofeedback sessions, their heartrate will be displayed on a screen which they can see as they practice biofeedback. The investigator coaching the participant during their clinic visit will read their real time heart rate from the screen and select the breathing frequency which is most optimal for heart rate variability, this is their resonant frequency. The participant will then carry out a regular biofeedback session for 20 minutes, breathing at their resonant frequency. At the initial visit, participants will complete surveys on their symptoms, quality of life and psychological well-being. Each participant will then be set up to carry out biofeedback sessions at home using their smartphone with a compatible application such as "HRV4Biofeedback", "EliteHRV", or a Polar H10. They will then be sent home to practice biofeedback for at least 10 to 20 minutes daily for six weeks. This will be done using applications on their smartphones (either HRV4Biofeedback or EliteHRV) which will guide them through slow breathing exercises and measure their heart rate using their smartphone camera and torch or a Polar H10 monitor connected via bluetooth. The heart rate variability data from each of these biofeedback sessions will be collected and analysed by study investigators. During this, they will remotely complete a weekly survey of their symptom experiences. Participants will also be given an Empatica E4 watch to wear only while they sleep. This will be used to measure their resting heart rate variability, outside of biofeedback sessions, This watch will not be used during biofeedback sessions. At the 6-week follow-up, participants will return to the clinic to complete another HRV biofeedback session and BSGM test, as well as complete the same surveys as the initial clinic visit.
Sponsors
The University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants must be at least 16 years old and meet Rome IV criteria for Functional Gastrointestinal Disorders (FGIDs), specifically limited to the upper gastrointestinal tract. This includes functional dyspepsia and chronic nausea and vomiting disorders or both if they meet criteria for both. Participants who also meet Rome IV criteria for disorders outside of the upper gastrointestinal system (i.e. irritable bowel syndrome) alongside their upper gastrointestinal disorder will not be excluded from the study. Participants must also be fluent in English and able to fully understand the risks and benefits of the research process.
Exclusion criteria
Individuals who have chronic gastrointestinal disorders and/or a history of gastrointestinal surgery will be excluded. Females who are pregnant and/or lactating will also be excluded. Participants who have a history of cardiac disease, arrhythmia, beta blockers, calcium channel blockers or other cardiac rate-control drugs will also be excluded. Patients will be required to sit in a reclined position for the duration of the study and so participants who are not able to do so will be excluded from the study. The adhesive array of electrodes used as part of the BSGM test has a slight risk of irritation post-removal (incidence rate 1-2%). Thus, participants who are susceptible to skin abrasions, tears and bruises as well as participants with allergies to adhesives will be excluded.
Outcome results
None listed