Correlates of GERD Symptom Severity

NCT03020550 | Completed Results DMC

• 2 other identifiers: 2016P0016281K23AT009218
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

GERD

Keywords

GERD; Galvanic Skin Response; Heart Rate Variability

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)

Other Outcomes (2)

• Post GERD Symptom Severity

  2 weeks (baseline and 2 week follow-up)

• Percent Change in Patient's GERD Symptoms

  2 weeks (baseline and 2 week follow-up)

Study Arms (1)

GERD Patients

Subjects with active GERD symptoms.

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with active GERD-related symptoms.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Equipment malfunction led to incomplete data collection for some subjects, reducing the total number of subjects in some of the data analyses.

Results Point of Contact

• Title: Michelle Dossett, MD, PhD
• Organization: University of California, Davis

mdossett@ucdavis.edu

916-734-5367

Study Officials

• Michelle Dossett, MD, PHD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 13, 2017
• Study Start: May 22, 2017
• Primary Completion: May 3, 2019
• Study Completion: May 7, 2019
• Last Updated: January 15, 2021
• Results First Posted: January 15, 2021

Record last verified: 2020-12

Locations

US (1)