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

NCT04253444 | Completed

• 1 other identifier: 278533
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastro Esophageal Reflux

Keywords

slow deep breathing; vagal nerve stimulation; reflux hypersensitivity

Outcome Measures

Primary Outcomes (1)

• The feasibility of 10 minutes twice a day for 4 weeks of slow deep breathing

  Compliance and acceptability are evaluated by the Global or general acceptability of treatment questionnaire. This is recorded as 'very good', 'good', 'fair', or 'poor'.

  4 weeks

Secondary Outcomes (5)

• The effect of slow deep breathing on anxiety

  4 weeks

• The effect of slow deep breathing on personality states.

  4 weeks

• The effect of slow deep breathing on depression.

  4 weeks

• Changes in vagal nerve activity before and after slow deep breathing protocol

  4 weeks

• Changes in symptoms before and after slow deep breathing

  4 weeks

Study Arms (2)

slow deep breathing

ACTIVE COMPARATOR

Patients are instructed to do deep breathing at full inspiratory capacity for 4 seconds followed by forced expiration in 6 seconds (forced vital capacity) for 10 minutes.

Behavioral: slow deep breathing

sham breathing

SHAM COMPARATOR

Patients are instructed to count 10 breaths and tick a box every time they count ten breaths. The counting distracts the patient reducing the effect of focussing of breathing on their autonomic nervous system.

Behavioral: sham breathing

Interventions

slow deep breathing BEHAVIORAL

Participants in this arm will be asked to do slow deep breathing (4 seconds inhalation and 6 seconds exhalation) for 10 minutes twice a day during the study period.

slow deep breathing

sham breathing BEHAVIORAL

Participants in this arm will be asked to do sham breathing for 10 minutes twice a day during the study period.

sham breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University of London

London, E1 2AJ, United Kingdom

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Qasim Aziz

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants and outcomes assessors will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised, sham-controlled, single-blinded, parallel study

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: April 16, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: February 14, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)