Vocal Biomarker Of Gastroesophageal Reflux
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 25-011472
About this study
The purpose of this study is to assess differences in acoustic, prosodic, and temporal voice features between patients with and without gastroesophageal reflux (GER) symptoms. To achieve this aim, we will study the differences in voice between patients with and without GER symptoms. Evaluate differences in acoustic, prosodic, and temporal voice features between individuals with GER before and after treatment with proton pump inhibitor (PPI) therapy. To achieve this, we will compare patients’ voice features at baseline and both 4- and 8-weeks after the initiation of acid suppression therapy. At minimum, patients will be instructed to take a standard, once-daily dose of a PPI. Patients will be asked to not significantly change their diet or other medications during this time period. Assess whether individuals with known Barrett’s esophagus exhibit unique acoustic, prosodic, and temporal voice features when compared to GER patients and healthy controls. To achieve this aim, we will study the differences in voice between patients with and without known Barrett’s esophagus. Evaluate whether the vocal profiles of patients with Barrett’s esophagus remain stable during ongoing PPI therapy over 8 weeks. To achieve this, we will compare patients’ voice features at baseline and both 4- and 8-weeks after the initiation of acid suppression therapy. At minimum, patients will be instructed to take a standard, once-daily dose of a PPI. Patients will be asked to not significantly change their diet or other medications during this time period.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Adults ≥18 years of age.
English-speaking.
Own a smartphone compatible with the recording application.
For GER group: ≥2 days/week of reflux symptoms (heartburn or regurgitation)
For Barrett’s group: previously diagnosed Barrett’s esophagus confirmed by endoscopy and/or biopsy, currently on stable PPI therapy for ≥4 weeks.
Exclusion Criteria:
Current upper respiratory infection.
History of significant speech or voice disorder.
Use of voice-modifying treatments (e.g., laryngeal surgery, vocal fold injections)
Chronic opioid use.
Prior surgery to esophagus or stomach.
Dysphagia
Known gastroparesis
Connective tissue disease affecting the esophagus.
Poorly controlled diabetes (HbA1c > 7.5%)
Active tobacco use.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/17/2025. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available