Comparison of Voice Therapy and Antireflex Therapy in LPR

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be a prospective, randomized, unblinded but controlled trial. Patients presenting to the Otolaryngology clinic who are diagnosed with laryngopharyngeal reflux disorder related dysphonia and meet inclusion criteria will be eligible to enroll in the study. Subjects will be randomized to one of three treatment arms, voice therapy, anti-reflux therapy, or a combination of voice therapy and anti-reflux therapy. Reflux symptom index (RSI) scores, reflux finding scores (RFS), voice handicap index-10 (VHI-10) scores, and consensus auditory perceptual evaluation-voice (CAPE-V) scores will be compared prior to initiation of therapy as well as at 1, 2, and 3 months following initiation of treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Temple University
• Treatments: Dexlansoprazole; Esomeprazole; Lansoprazole; Omeprazole

Criteria

Inclusion Criteria:

• 18 years of age and older

• Hoarseness

• Reflux symptom index score >13

• Reflux finding score >7

• English speaking

Exclusion Criteria:

• Evidence of other laryngeal pathology

• Esophageal dysmotility

• Gastroesophageal reflux

• Currently on anti-reflux medications

• Presence of a neurologic condition

• Active smoking

• Currently pregnant

• Individuals unable to consent for themselves

• Recent upper respiratory infection lasting more than 1 month

• Prior treatment for laryngopharyngeal reflux.