Laryngopharyngeal Reflux, Cough, Throat Clearing, Dysphonia, Reflux
Conditions
Brief summary
The goal of this clinical trial is to learn if a mechanism guided strategy that utilizes a multidisciplinary approach to treat adults patients (age 18-89) with chronic throat symptoms who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) is more effective than the usual care strategy with proton pump inhibitor (PPI) therapy used in gastroenterology for these patients. The main question it aims to answer is: Will a greater proportion of the mechanism guided strategy participants achieve symptom response in comparison to the usual care strategy participants? If there is a comparison group: Researchers will compare the mechanism guided strategy to usual care strategy to see if treatment response differs between the groups. Participants will be be asked to do the following: * participate in an 8-week blinded study phase where they will be randomized to either 1) Mechanism Guided Strategy or 2) Usual Care Strategy * take an oral capsule daily (omeprazole 40mg or placebo) * come to 3 in-person visits at UC San Diego Health for an intervention visit with a study provider * consider incorporating recommended lifestyle modifications * complete weekly surveys
Detailed description
This research study is being conducted to compare the efficacy between usual care and a novel mechanism guided strategy for adults with chronic throat (laryngeal) symptoms undergoing evaluation for laryngopharyngeal reflux (LPR). Usual care strategy is used clinically and is known to reduce chronic throat symptoms. The mechanism guided strategy is a new treatment that personalizes the application of acid suppression medication and voice therapy to the patient. The mechanism guided strategy is being evaluated for how well it works in patients with these throat symptoms. Participants who are undergoing clinical evaluation for laryngopharyngeal reflux (LPR) inclusive of an upper endoscopy with ambulatory pH monitoring (reflux testing) will be recruited for participation in this study. Participants will undergo screening to confirm eligibility. Once informed consent is administered and signed, participants will be asked about their demographic background, current symptoms, brief medical history, and current medications. Screening takes place within 30 days of a participant's scheduled clinical upper endoscopy with reflux testing. After completing the clinical upper endoscopy and reflux testing, they will be scheduled for their first intervention visit, about 1 week later. Participants will be randomized to 1 of 2 arms with of the study: 1) Mechanism Guided Strategy or 2) Usual Care Strategy. Randomization is 1:1 based on permuted block randomization in REDCap to mechanism guided or usual care strategy with stratification by concomitant esophageal + laryngeal symptoms versus isolated laryngeal symptoms. Participants will then attend 3 in person treatment visits at UC San Diego Health's Research Clinic. Participants will undergo measures at these visits included: 1) acoustics, 2) aerodynamics, 3) patient reported outcomes measuring symptom burden and quality of life, 4) Fasting saliva samples for pepsin and bile acid analysis, and 5) physiologic measures. The study team will also collect height, weight, current medications, and adverse events. Participants will be dispensed an oral capsule (omeprazole 40mg or placebo) based on their randomly assigned strategy. The participants in the mechanism guided strategy will receive omeprazole 40mg daily if their clinical upper endoscopy and reflux testing are conclusive with GERD. They will receive placebo if their upper endoscopy and reflux testing are not conclusive with GERD. The participants in the usual care strategy will receive omeprazole 40mg daily regardless of the results of their upper endoscopy and reflux testing. Participants will meet with a study provider who will administer treatment according to assigned arm and provide recommended lifestyle modifications. Participants will complete an online survey weekly to indicate if they have taken their oral capsule daily and if they have incorporated recommended lifestyle modifications. Intervention visits will take place during week 1, week 4, and week 8. After the week 8 intervention visit is complete, participants will be told which strategy they were assigned to, if they are taking omeprazole 40mg or placebo, and be transitioned back to clinical care. The most common risks or discomforts of this study are emotional upset during symptom reflection and side effects of omeprazole. The most serious risks include side effects of omeprazole which include generally mild side effects: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.
Interventions
DRUGOmeprazole 40 MG
8 week double dose therapy of proton pump inhibitor or placebo.
BEHAVIORALLaryngeal Recalibration Therapy
LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms. Each session with the SLP will guide subjects through these therapies. The existing script-based LRT protocol consists of the following: 1) mechanical guidance (laryngeal suppression, voice production, breath coordination), 2) cognitive guidance (identification of thinking patterns, recalibration of thoughts about laryngeal sensations).
BEHAVIORALGERD Lifestyle Recommendations
This is the typical lifestyle recommendations for GERD used clinically.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participant will not know which strategy group they are randomized to and they will not know which daily oral capsule (omeprazole 40mg or placebo) they have been dispensed. The study provider they meet with during intervention visits will not know the results of their upper endoscopy and reflux testing.
Intervention model description
8 week intervention with a daily oral capsule (omeprazole 40mg or placebo) and 3 intervention visits at week 1, 4, and 8.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. 18-89 years of age 2. \>8 weeks of laryngeal symptoms (cough, throat clearing, dysphonia) 3. Standard evaluation for LPR, undergoing EGD (with endoscopic evaluation of the hypopharynx) and reflux monitoring off acid suppression 4. Off acid suppression therapy for at least 2 weeks prior to randomization.
Exclusion criteria
1. PPI intolerance and/or known hypersensitivity to the formulation or substituted benzimidazoles 2. History of foregut surgery 3. Known diagnosis of achalasia 4. Inability to fast for 4 hours (no food or drink) 5. Active tobacco use 6. Pregnant or breastfeeding 7. Unable to consent in English or Spanish 8. Unable to provide consent without a legal guardian or representative 9. Imprisoned 10. Endoscopic findings conclusive with esophageal mucosal abnormalities 11. Unable to proceed with reflux monitoring 12. Use of acid suppression during the reflux monitoring and/or before the study medication (omeprazole or placebo) is dispensed 13. Prior LRT for reflux related symptoms 14. History of major psychiatric comorbidity 15. Unable to attend in person study visits at UCSD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Response | 5 years | Proportion of subjects with symptom response measured by the reflux symptom index (RSI) score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Methods for LPR | 5 years | Symptom response to PPI measured by the RSI score |
Countries
United States
Contacts
Primary ContactLorijane Robles
Outcome results
None listed