Recruiting

Mechanism Guided Strategy

Sponsor:

UCLA

Code:

NCT06999577

Conditions

Laryngopharyngeal Reflux

Cough

Throat Clearing

Dysphonia

Reflux

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Omeprazole 40 MG

Laryngeal Recalibration Therapy

GERD Lifestyle Recommendations

Study Details

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

Conditions

Laryngopharyngeal Reflux

Cough

Throat Clearing

Dysphonia

Reflux

Study ID

NCT06999577

Start date

Jun 4, 2025

Status verified date

Jul, 2025

Completion date

Jul 1, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Mechanism Guided Strategy

1\) 8-week course of double dose PPI or placebo; 2) Laryngeal Recalibration Therapy (LRT) with speech language pathologist (SLP). Subjects will receive PPI if their reflux monitoring is consistent with GERD and placebo if it is not consistent with GERD. SLP will administer LRT: LRT utilizes therapies that SLPs standardly utilize (mechanical and cognitive guidance) in combination specifically designed to treat laryngeal symptoms.

1. Mechanical Guidance: The SLP will guide subjects through laryngeal suppression, changing voice production, and improving breath coordination.
2. Cognitive Guidance: The SLP will guide subjects through relaxation and conceptualization changes.
3. Lifestyle Recommendations: In addition to receiving LRT, subjects will be counseled on typical lifestyle recommendations for GERD, detailed in the Usual Care Strategy below.

active comparator: Usual Care Strategy

1\) an 8-week course of double dose PPI and 2) lifestyle counseling. This represents the control group receiving usual care and will serve as the study's active control group. In order to maintain group concealment, subjects will receive counseling from a study investigator on standard lifestyle modifications recommended for GERD at intervals mirroring that of the mechanism guided strategy: week 1, week 4, and week 8 which is also reflective of standard recommended follow-up and counseling in GERD management.

Interventions

Omeprazole 40 MG

8 week double dose therapy of proton pump inhibitor or placebo.

Laryngeal 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).

GERD Lifestyle Recommendations

This is the typical lifestyle recommendations for GERD used clinically.

Primary outcome measure

  • Symptom Response [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Lorijane Robles

858-246-5236esophagealresearch@health.ucsd.edu

Locations

University of California San Diego

Recruiting

San Deigo, California, United States, 92093

Contacts

Esophageal Clinical Research Coordinator

858-822-0391lnrobles@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-08-01.