Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT03020550
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2016-12-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Correlates of GERD Symptom Severity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mdossett@ucdavis.edu', 'phone': '916-734-5367', 'title': 'Michelle Dossett, MD, PhD', 'organization': 'University of California, Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Equipment malfunction led to incomplete data collection for some subjects, reducing the total number of subjects in some of the data analyses.'}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Visit', 'description': 'Patients with GERD receiving a standard medical visit', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Expanded Visit', 'description': 'Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastroenteritis', 'notes': '1 subject developed gastroenteritis and presented to the emergency department where they received IV fluids. Adverse event deemed not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Association of Change in Patient's GSR From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later", 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Visit', 'description': 'Patients with GERD receiving a standard medical visit'}, {'id': 'OG001', 'title': 'Expanded Visit', 'description': 'Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in GSR (galvanic skin response). No term for visit type assignment was included in the model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline GERD symptom severity.'}], 'paramType': 'MEAN', 'timeFrame': 'Beginning to end of study visit (1 hour or less for change in GSR)', 'description': '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.', 'unitOfMeasure': 'micro-Siemens', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis. Subjects with missing GSR data (due to equipment malfunction) were not included in the final analysis.'}, {'type': 'PRIMARY', 'title': "Association of Change in Patient's High Frequency HRV From Beginning to End of Study Visit With GERD Symptom Severity 2 Weeks Later", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Visit', 'description': 'Patients with GERD receiving a standard medical visit'}, {'id': 'OG001', 'title': 'Expanded Visit', 'description': 'Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in RMSSD (high frequency HRV). No term for visit type assignment was included in the model.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline GERD symptom severity'}], 'paramType': 'MEAN', 'timeFrame': 'Beginning to end of study visit (1 hour or less for change in HRV/RMSSD)', 'description': '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.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat analysis.'}, {'type': 'PRIMARY', 'title': "Correlation Between Concordance in GSR Between Patient and Physician During the Study Visit and Percent Change in Patients' GERD Symptoms Over 2 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Visit', 'description': 'Patients with GERD receiving a standard medical visit'}, {'id': 'OG001', 'title': 'Expanded Visit', 'description': 'Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0536', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.199', 'spread': '0.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "The outcome measure was calculated using a Pearson correlation to compare the session index representing the amount of concordance in GSR between patient and physician and the percent change in patients' GERD symptoms. Visit type assignment was not included in the analysis.", 'statisticalMethod': "Pearson's correlation test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Beginning to end of study visit (1 hour or less for concordance between patient and physician GSR)', 'description': '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.', 'unitOfMeasure': 'Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat. Subjects with missing GSR data (due to equipment malfunction) were not included in the final analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Post GERD Symptom Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Visit', 'description': 'Patients with GERD receiving a standard medical visit'}, {'id': 'OG001', 'title': 'Expanded Visit', 'description': 'Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation'}], 'classes': [{'categories': [{'measurements': [{'value': '3.77', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks (baseline and 2 week follow-up)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Percent Change in Patient's GERD Symptoms", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Visit', 'description': 'Patients with GERD receiving a standard medical visit'}, {'id': 'OG001', 'title': 'Expanded Visit', 'description': 'Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '45', 'groupId': 'OG000'}, {'value': '-12.2', 'spread': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks (baseline and 2 week follow-up)', 'description': "Percent change in patient's GERD symptoms was calculated as: (post GERD symptom severity - baseline GERD symptom severity) / baseline GERD symptom severity\\*100.\n\nGERD 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\\]).", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Visit', 'description': 'A standardized visit (based on a pre-set question template) modeled after a primary care visit focused on evaluating GERD symptoms.'}, {'id': 'FG001', 'title': 'Expanded Visit', 'description': 'A standardized visit (based on a pre-set question template) modeled after an integrative medicine visit for GERD symptoms. The Expanded Visit includes all of the questions in the Standard Visit plus additional questions about the nature of the GI symptoms (e.g., taste of reflux, food cravings and aversions), other health issues, and the patient\'s temperament (e.g., shy, anxious, caring). Some of these questions address the patient\'s "constitutional type" as might be assessed by some integrative practitioners (e.g., tell me about your sleep; do you tend to be hot or cold?).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Visit', 'description': 'Patients with GERD receiving a standard medical visit'}, {'id': 'BG001', 'title': 'Expanded Visit', 'description': 'Patients with GERD receiving an expanded medical visit modeled after an integrative medicine consultation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '15.7', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '39.9', 'spread': '16.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average Daily GERD Symptom Severity', 'classes': [{'categories': [{'measurements': [{'value': '3.90', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '2.95', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '3.26', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Severity of GERD symptoms were assessed by participant self-report on a 7-day symptom diary for one week immediately prior to enrolling in the study. 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 values across each of the 7 days were averaged to create the average daily GERD symptom severity score. Adapted from: Miner P, et. al. Am J Gastroenterol. 2002 Jun;97(6):1332-1339. PMID: 12094846', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-08', 'size': 655719, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-26T17:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-22', 'studyFirstSubmitDate': '2016-12-20', 'resultsFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-22', 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Post GERD Symptom Severity', 'timeFrame': '2 weeks (baseline and 2 week follow-up)', 'description': '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.'}, {'measure': "Percent Change in Patient's GERD Symptoms", 'timeFrame': '2 weeks (baseline and 2 week follow-up)', 'description': "Percent change in patient's GERD symptoms was calculated as: (post GERD symptom severity - baseline GERD symptom severity) / baseline GERD symptom severity\\*100.\n\nGERD 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\\])."}], 'primaryOutcomes': [{'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)', 'description': '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.'}, {'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)', 'description': '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.'}, {'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)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GERD', 'Galvanic Skin Response', 'Heart Rate Variability'], 'conditions': ['GERD']}, 'descriptionModule': {'briefSummary': 'This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with active GERD-related symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ages 21-70 years old\n* 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\n* English language proficiency\n* Willingness to be videotaped and connected to physiologic monitoring devices during the visit\n\nExclusion Criteria:\n\n* 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\n* Heavy alcohol use (\\> 6 drinks/week for women and \\> 13 drinks/week for men)\n* Pregnant women.\n* Dementia or significant memory difficulties\n* Severe, unstable psychiatric disease\n* 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\n* Failure to complete the baseline symptom diary for at least 6 of 7 days\n* 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)\n* Allergy to adhesives\n* Inability to provide informed consent"}, 'identificationModule': {'nctId': 'NCT03020550', 'briefTitle': 'Correlates of GERD Symptom Severity', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Physiologic and Behavioral Correlates of GERD Symptom Severity', 'orgStudyIdInfo': {'id': '2016P001628'}, 'secondaryIdInfos': [{'id': '1K23AT009218', 'link': 'https://reporter.nih.gov/quickSearch/1K23AT009218', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'GERD Patients', 'description': 'Subjects with active GERD symptoms.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michelle Dossett, MD, PHD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Physician', 'investigatorFullName': 'Michelle Dossett, MD, PhD, MPH', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}