GERDNCT03020550

Correlates of GERD Symptom Severity

An observational study of GERD, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD). Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: GERD
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 22 May 2017to 7 May 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adults with active GERD-related symptoms.

Who may be able to join

Adults ages 21-70 years old
Heartburn symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7 day baseline symptom diary
English language proficiency
Willingness to be videotaped and connected to physiologic monitoring devices during the visit

Who cannot join

Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men)
Pregnant women.
Dementia or significant memory difficulties
Severe, unstable psychiatric disease
Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study

Show all 10Show fewer

Failure to complete the baseline symptom diary for at least 6 of 7 days
Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
Allergy to adhesives
Inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Physiologic and Behavioral Correlates of GERD Symptom Severity

This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD).

Read the detailed description

Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms. We will measure heart rate variability and galvanic skin response in patients during the visits and video record the visits. Subjects will complete a daily GERD symptom diary for 2 weeks and then return to the study center to complete additional questionnaires and an exit interview.

Conditions: GERD
Keywords: GERD, Galvanic Skin Response, Heart Rate Variability
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03020550
Study group	Role	What they receive
GERD Patients		Subjects with active GERD symptoms.

What is being measured

The primary outcome is the main question the study is designed to answer.

Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
Galvanic skin response (GSR) was measured with a device from ADInstruments during the baseline study visit. Values ranged from 0.93 - 12 micro-Siemens (μS). Change in GSR was calculated as mean value of GSR for the first 2 minutes of the study visit minus mean value of GSR for the last 2 minutes of the study visit.
Measured: Beginning to end of study visit (1 hour or less for change in GSR)
Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
Heart rate variability (HRV) was measured using a device from ADInstruments gathering data at 256 Hz. We used the RMSSD (Root Mean Square of the Successive Differences) value as a proxy for high frequency HRV. Measured values ranged from 0 - 150 msec. Change in high frequency HRV was calculated as the RMSSD value for the first 5 minutes of the study visit minus the RMSSD value for the last 5 minutes of the study visit.
Measured: Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)
Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks
Concordance in galvanic skin response (GSR) between patient and physician was calculated using an established approach (Marci CD, 2007; PMID 17299296) to create a single index value for the visit. The natural logarithm of this value was taken to reduce skew. A value greater than 0 means more than 50% concordance in the data, a value less than zero means less than 50% concordance in the data.
Measured: Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 20177 May 2019

First posted13 Jan 2017 (estimated)
Study start22 May 2017
Primary completion3 May 2019
Study completion7 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GERDStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03020550
Sponsor's protocol ID: 2016P001628
Other IDs: 1K23AT009218
Status last verified: Dec 2020
First submitted: 20 Dec 2016
Last updated: 15 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
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Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
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Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
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Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease

All GERD trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiologic and Behavioral Correlates of GERD Symptom Severity
ClinicalTrials.gov ID: NCT03020550
Acronym / sponsor ID: 2016P001628
Conditions: GERD
Keywords: GERD, Galvanic Skin Response, Heart Rate Variability
Study type: Observational
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 22 May 2017 (actual)
Primary completion: 3 May 2019 (actual)
Study completion: 7 May 2019 (actual)
First posted: 13 Jan 2017 (estimated)
Results: Posted 15 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD).

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
GERD Patients	–	–Subjects with active GERD symptoms.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adults with active GERD-related symptoms.

Key inclusion criteria (4 listed)

Adults ages 21-70 years old
Heartburn symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7 day baseline symptom diary
English language proficiency
Willingness to be videotaped and connected to physiologic monitoring devices during the visit

Key exclusion criteria (10 listed)

Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men)
Pregnant women.
Dementia or significant memory difficulties
Severe, unstable psychiatric disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
Time frame: Beginning to end of study visit (1 hour or less for change in GSR)
Galvanic skin response (GSR) was measured with a device from ADInstruments during the baseline study visit. Values ranged from 0.93 - 12 micro-Siemens (μS). Change in GSR was calculated as mean value of GSR for the first 2 minutes of the study visit minus mean value of GSR for the last 2 minutes of the study visit.
Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
Time frame: Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)
Heart rate variability (HRV) was measured using a device from ADInstruments gathering data at 256 Hz. We used the RMSSD (Root Mean Square of the Successive Differences) value as a proxy for high frequency HRV. Measured values ranged from 0 - 150 msec. Change in high frequency HRV was calculated as the RMSSD value for the first 5 minutes of the study visit minus the RMSSD value for the last 5 minutes of the study visit.
Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks
Time frame: Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)
Concordance in galvanic skin response (GSR) between patient and physician was calculated using an established approach (Marci CD, 2007; PMID 17299296) to create a single index value for the visit. The natural logarithm of this value was taken to reduce skew. A value greater than 0 means more than 50% concordance in the data, a value less than zero means less than 50% concordance in the data.

Results and safety

Results posted to the registry on 15 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Visit	8	8
Expanded Visit	16	16

Primary outcome: Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later

Time frame: Beginning to end of study visit (1 hour or less for change in GSR). Mean (Standard Deviation). Unit: micro-Siemens

Measure	Standard Visit n = 7	Expanded Visit n = 9
Value	-0.94 (1.3)	-1.70 (1.1)

Standard Visit vs Expanded Visit: p = 0.034, ANOVA

Population analysed: Intent to treat analysis. Subjects with missing GSR data (due to equipment malfunction) were not included in the final analysis.

Primary outcome: Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later

Time frame: Beginning to end of study visit (1 hour or less for change in HRV/RMSSD). Mean (Standard Deviation). Unit: milliseconds

Measure	Standard Visit n = 8	Expanded Visit n = 16
Value	-0.26 (8.3)	2.5 (10.3)

Standard Visit vs Expanded Visit: p = 0.56, ANOVA

Population analysed: Intent to treat analysis.

Primary outcome: Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks

Time frame: Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR). Mean (Standard Deviation). Unit: Index

Measure	Standard Visit n = 7	Expanded Visit n = 9
Value	-0.0536 (0.19)	0.199 (0.38)

Standard Visit vs Expanded Visit: p = 0.80, Pearson's correlation test

Population analysed: Intent to treat. Subjects with missing GSR data (due to equipment malfunction) were not included in the final analysis.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Visit	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
Expanded Visit	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Limitations and caveats (from the sponsor): Equipment malfunction led to incomplete data collection for some subjects, reducing the total number of subjects in some of the data analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for GERD

Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease

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.

Michelle Dossett, MD, PHD, MPH principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of GERD, run by Massachusetts General Hospital at 1 site in United States.

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 4 inclusion and 10 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 15 Jan 2021. 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 States. 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. 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?

Yes. Results are posted in the registry (first posted 15 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later (time frame: Beginning to end of study visit (1 hour or less for change in GSR)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03020550.

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 15 Jan 2021.