N/A
N=24
Correlates of GERD Symptom Severity
GERD
Bottom Line
View on ClinicalTrials.gov: NCT03020550 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later — -0.94; -1.70 micro-Siemens — p=0.034
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later |
-0.94; -1.70 | 0.034 sig |
| PRIMARY Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later |
-0.26; 2.5 | 0.56 |
| PRIMARY Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks |
-0.0536; 0.199 | 0.80 |
Summary
This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03020550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.