Correlates of GERD Symptom Severity

Mass General Brigham

Status: Completed

Conditions: GERD

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03020550

1K23AT009218 (U.S. NIH Grant/Contract)

2016P001628

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

GERD Patients

Description:

Subjects with active GERD symptoms.