Clinical trial NCT03020550: Correlates of GERD Symptom Severity
Official title: Physiologic and Behavioral Correlates of GERD Symptom Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: GERD
Keywords: GERD
Galvanic Skin Response
Heart Rate Variability
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with active GERD-related symptoms.

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

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.

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

Primary outcomes:
measure: Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
timeFrame: Beginning to end of study visit (1 hour or less for change in GSR)
measure: Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later
timeFrame: Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)
measure: Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks
timeFrame: Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)
Secondary outcomes:
Other outcomes:
measure: Post GERD Symptom Severity
timeFrame: 2 weeks (baseline and 2 week follow-up)
measure: Percent Change in Patient's GERD Symptoms
timeFrame: 2 weeks (baseline and 2 week follow-up)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michelle Dossett, MD, PHD, MPH
role: PRINCIPAL_INVESTIGATOR
References: