Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000691549
Ethics application status
Approved
Date submitted
15/05/2024
Date registered
30/05/2024
Date last updated
30/05/2024
Date data sharing statement initially provided
30/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gastric motility rhythms response to heart rate variability biofeedback interventions
Scientific title
Gastric motility rhythms response to heart rate variability biofeedback interventions in individuals with functional upper gastrointestinal disorders
Secondary ID [1] 312156 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
functional dyspepsia 333804 0
chronic nausea and vomiting syndrome 333805 0
Condition category
Condition code
Oral and Gastrointestinal 330474 330474 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328598 0
Treatment: Other
Comparator / control treatment
We will not be using a control group for this trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338248 0
A change in gastric motility
Timepoint [1] 338248 0
At baseline and at the 6 week follow-up
Secondary outcome [1] 435144 0
changes in Gut-Brain Well-being
Timepoint [1] 435144 0
at baseline and 6 week follow-up
Secondary outcome [2] 435145 0
Depression
Timepoint [2] 435145 0
At baseline and 6 weeks post-baseline
Secondary outcome [3] 435146 0
Gastrointestinal symptom scores
Timepoint [3] 435146 0
at baseline and then at 1, 2, 3, 4, 5, and 6 weeks post-baseline
Secondary outcome [4] 435147 0
Gastrointestinal symptoms
Timepoint [4] 435147 0
at baseline and 6 weeks post-baseline
Secondary outcome [5] 435148 0
Quality of life
Timepoint [5] 435148 0
at baseline and 6 weeks post-baseline
Secondary outcome [6] 435149 0
Change in autonomic function (during biofeedback sessions)
Timepoint [6] 435149 0
at baseline and then daily for 6 weeks post-baseline
Secondary outcome [7] 435456 0
Anxiety
Timepoint [7] 435456 0
At baseline and 6 week follow-up
Secondary outcome [8] 435457 0
Stress
Timepoint [8] 435457 0
At baseline and 6 week follow-up
Secondary outcome [9] 435684 0
Change in resting autonomic function (during sleep)
Timepoint [9] 435684 0
As many nights as possible between study initiation and final 6-week follow-up

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/05/2024
Date of last participant enrolment
Anticipated
23/08/2024
Actual
Date of last data collection
Anticipated
4/10/2024
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 26310 0
New Zealand
State/province [1] 26310 0

Funding & Sponsors
Funding source category [1] 316520 0
University
Name [1] 316520 0
The University of Auckland through the Health Research Council Programme
Country [1] 316520 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 318706 0
None
Name [1] 318706 0
none
Address [1] 318706 0
Country [1] 318706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315314 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 315314 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 315314 0
New Zealand
Date submitted for ethics approval [1] 315314 0
19/04/2024
Approval date [1] 315314 0
26/04/2024
Ethics approval number [1] 315314 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134306 0
A/Prof Greg O'Grady
Address 134306 0
Alimetry, 86 Symonds Street, Grafton, Auckland, New Zealand
Country 134306 0
New Zealand
Phone 134306 0
+64 09 923 9820
Fax 134306 0
Email 134306 0
greg.ogrady@auckland.ac.nz
Contact person for public queries
Name 134307 0
Greg O'Grady
Address 134307 0
Alimetry, 86 Symonds Street, Grafton, Auckland, New Zealand
Country 134307 0
New Zealand
Phone 134307 0
+64 09 923 9820
Fax 134307 0
Email 134307 0
greg.ogrady@auckland.ac.nz
Contact person for scientific queries
Name 134308 0
Greg O'Grady
Address 134308 0
Alimetry, 86 Symonds Street, Grafton, Auckland, New Zealand
Country 134308 0
New Zealand
Phone 134308 0
+64 09 923 9820
Fax 134308 0
Email 134308 0
greg.ogrady@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.