Study Results
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View full resultsBasic Information
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COMPLETED
24 participants
OBSERVATIONAL
2017-05-22
2019-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GERD Patients
Subjects with active GERD symptoms.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
70 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Michelle Dossett, MD, PhD, MPH
Assistant Physician
Principal Investigators
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Michelle Dossett, MD, PHD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016P001628
Identifier Type: -
Identifier Source: org_study_id
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