The Effect of Autonomic Modulation on Symptoms in Patients With Reflux Hypersensitivity

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    40
  • sponsor
    Queen Mary University of London
Updated on 9 August 2021
regurgitation
heartburn
esophagitis
acidity

Summary

Reflux hypersensitivity is the disease that causes chest pain, heartburn and regurgitation and can impair patients' quality of life. Pain modulators are often used for the treatment of reflux hypersensitivity, but the effect is not enough and more effective therapy is needed.

Slow deep breathing is the validated method to modulate the autonomic nervous system. In our previous study, slow deep breathing could increase the threshold of oesophageal pain in healthy volunteers. Therefore, slow deep breathing has the potential to be an effective treatment for reflux hypersensitivity and further study is warranted in the patient group.

The aims of this study are (1) to evaluate the feasibility of slow deep breathing and (2) to investigate the effect of autonomic nerve modulation by slow deep breathing on symptoms in patients with reflux hypersensitivity.

Description

This is a randomized single-blinded parallel study and the investigators aim to recruit 40 participants.

Patients will be enrolled for a period of 4 weeks and don't have to attend our institution. A video chat on day 1 will consist of confirming eligibility, after which the patient will be randomised to follow either the slow deep breathing protocol or the sham breathing protocol in a single blinded fashion. That is, the patient will be unaware of which the active breathing exercise is. Once randomised during a video chat, they will undergo baseline heart rate variability (HRV) measurements using a smartphone app, answer the questionnaires on Research Electronic Data Capture (REDCap), and then practice the relevant breathing exercise with an instruction video. The patient will then be trained to self-administer the breathing exercise during a video chat, which will be used twice a day for 10 minutes over the next 4 weeks with a standardized instruction video.

This study finishes when participants answer the online questionnaire and record HRV on day 29.

The investigators will set up this questionnaire on our electronic data capture system (Research Electronic Data Capture: REDCap). Participants will answer questionnaires using this online system on day 1, day 8, day15, day 22, and day 29 (end of the study).

Therefore, participants will also be trained on how to use REDCap and answer questionnaires under supervision on day 1 during a video chat. Questionnaires on day 8, 15, 22, and 29 will be answered at home. The investigators will send a reminder message to participants using a REDCap system the day before they answer the questionnaire.

Participants will be asked to record their HRV using a smartphone app on day 1, 8, 15, 22, and 29.

Details
Condition Gastroesophageal Reflux, Gastroesophageal Reflux Disease (GERD), gastroesophageal reflux disease, esophageal reflux, gerd, gastric reflux, gastro-oesophageal reflux
Treatment slow deep breathing, sham breathing
Clinical Study IdentifierNCT04253444
SponsorQueen Mary University of London
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female patients over the age of 18 years
Women in the follicular phase of the menstrual cycle (visits will be arranged so that in menstruating women, the study will be started in the follicular phase of the menstrual cycle to standardise for possible confounding effects of the menstrual cycle on symptom perception)
Able to give informed consent
Able to speak and understand English without the need for an interpreter
No evidence of erosive esophagitis by OGD
Presence of chest pain, heartburn, and/or regurgitation 3 days/week
Normal acid exposure on MII-pH
Positive symptom reflux association on MII-pH (symptom index 50% and symptom association probability 95%)
OGD is performed within 2 years before the enrolment
MII-pH study is performed within 2 year before the enrolment

Exclusion Criteria

Current or previous GI or medical illnesses that may affect ANS / GI function
Current or previous significant CNS illness
Current medications affecting the CNS, GI or ANS systems
Pregnancy and lactation
Cardiac dysrhythmias
Those who do not have access to the internet-based questionnaire
The use of acid suppression therapies (e.g. proton pump inhibitor or H2 blocker) or pain modulators (e.g. low-dose Tricyclic Antidepressants, TCAs or Selective Serotonin Reuptake Inhibitors, SSRI) does not change the decision of participation as long as above-mentioned symptoms remain
Patients are asked to refrain from smoking for 12 hours and drinking alcohol
as well as using recreational drugs for 48 hours prior to study visit
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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