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Completed

NCT Number: NCT03020550

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).

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Post GERD Symptom Severity

    Time frame: 2 weeks (baseline and 2 week follow-up)

    GERD symptom severity at follow-up was assessed by self-report on a 7-day symptom diary (symptoms collected days 8-14 after the study visit). Possible daily scores ranged from 0-12 with higher scores indicating more severe symptoms (sum of daytime heartburn, nighttime heartburn, and acid regurgitation symptoms each rated 0-4 in severity [none, mild, moderate, severe, very severe]). Daily scores across the 7 days were averaged to create the Post GERD symptom severity score. Adapted from: Miner P, et. al. Am J Gastroenterol. 2002. PMID: 12094846.

  2. Percent Change in Patient's GERD Symptoms

    Time frame: 2 weeks (baseline and 2 week follow-up)

    Percent change in patient's GERD symptoms was calculated as: (post GERD symptom severity - baseline GERD symptom severity) / baseline GERD symptom severity*100.

    GERD symptom severity scores were averaged across 7 day baseline and follow-up periods from a symptom diary (adapted from Miner P, 2002; PMID 12094846). Scores ranged from 0-12 with higher scores indicating more severe symptoms (sum of daytime heartburn, nighttime heartburn, and acid regurgitation each rated 0-4 in severity [none, mild, moderate, severe, very severe]).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Physiologic and Behavioral Correlates of GERD Symptom Severity

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2017
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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