The Mechanism Versus PPI Trial

PHASE4RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

June 4, 2025

Primary Completion Date

May 1, 2029

Study Completion Date

July 1, 2029

Conditions
Laryngopharyngeal RefluxCoughThroat ClearingDysphoniaReflux
Interventions
DRUG

Omeprazole 40 MG

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

BEHAVIORAL

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).

BEHAVIORAL

GERD Lifestyle Recommendations

This is the typical lifestyle recommendations for GERD used clinically.

Trial Locations (1)

92093

RECRUITING

University of California San Diego, San Deigo

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of California, San Diego

OTHER