Gastro Esophageal RefluxNCT04253444
The Effect of Autonomic Modulation on Symptoms in Patients With Reflux Hypersensitivity
A study testing slow deep breathing in people with Gastro Esophageal Reflux, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- slow deep breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Single Blinded Parallel Study to Investigate the Physiological Modulation of the Autonomic Nervous System on Symptoms in Patients With Reflux Hypersensitivity
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.
Read the detailed 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.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- slow deep breathing, sham breathing
- Keywords
- slow deep breathing, vagal nerve stimulation, reflux hypersensitivity
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
slow deep breathingBehavioural
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.
sham breathingBehavioural
Participants in this arm will be asked to do sham breathing for 10 minutes twice a day during the study period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: sham breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 4 weeks
Secondary outcomes (5)
The effect of slow deep breathing on anxiety
State and Trait Anxiety Inventory state (Maximun and minimum values are 80 and 20, respectively. The higher value indicates more nervous status.) and State and Trait Anxiety Inventory trait (Maximun and minimum values are 80 and 20, respectively. The higher value indicates more nervous trait) are used.
Measured: 4 weeks
The effect of slow deep breathing on personality states.
Big five inventory questionnaire (44 items) is used. This is a self-report inventory designed to measure the personality type.
Measured: 4 weeks
The effect of slow deep breathing on depression.
Hospital Anxiety and Depression Scale is used. The maximun and minimum values are 21 and 0, respectively (0-7 = Normal, 8-10 = Borderline,11-21 = Abnormal).
Measured: 4 weeks
Changes in vagal nerve activity before and after slow deep breathing protocol
Cardiac vagal tone, which is an indicator of vagal nerve activity and caluculated from R-R interval of electrocardiogram, is used for the evaluation.
Measured: 4 weeks
Changes in symptoms before and after slow deep breathing
Reflux symptom questionnaire, 7 day recall is used for the evaluation. This can categorize the symptom into 'did not have', 'very mild', 'mild', 'moderate', 'moderately severe', or 'severe'.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start16 Apr 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised, sham-controlled, single-blinded, parallel study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qasim Aziz, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253444
- Sponsor's protocol ID
- 278533
- Status last verified
- Oct 2022
- First submitted
- 27 Jan 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single Blinded Parallel Study to Investigate the Physiological Modulation of the Autonomic Nervous System on Symptoms in Patients With Reflux Hypersensitivity
- ClinicalTrials.gov ID
- NCT04253444
- Acronym / sponsor ID
- 278533
- Conditions
- Gastro Esophageal Reflux
- Keywords
- slow deep breathing, vagal nerve stimulation, reflux hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomised, sham-controlled, single-blinded, parallel study
| Arm | Type | Receives |
|---|---|---|
| slow deep breathing | Active comparator | Behavioral: slow deep breathingPatients 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. |
| sham breathing | Sham comparator | Behavioral: sham breathingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| slow deep breathingParticipants 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. | Behavioural | slow deep breathing |
| sham breathingParticipants in this arm will be asked to do sham breathing for 10 minutes twice a day during the study period. | Behavioural | sham breathing |
Primary outcome
The feasibility of 10 minutes twice a day for 4 weeks of slow deep breathing
Time frame: 4 weeks
Compliance and acceptability are evaluated by the Global or general acceptability of treatment questionnaire. This is recorded as 'very good', 'good', 'fair', or 'poor'.
5 secondary outcomes
The effect of slow deep breathing on anxiety
Time frame: 4 weeks
The effect of slow deep breathing on personality states.
Time frame: 4 weeks
The effect of slow deep breathing on depression.
Time frame: 4 weeks
Changes in vagal nerve activity before and after slow deep breathing protocol
Time frame: 4 weeks
Changes in symptoms before and after slow deep breathing
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qasim Aziz principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing slow deep breathing in people with Gastro Esophageal Reflux, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of 10 minutes twice a day for 4 weeks of slow deep breathing (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.