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Comparison of Voice Therapy and Antireflex Therapy in LPR

NCT02530879 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-05-18

No results posted yet for this study

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.

Conditions

  • Laryngopharyngeal Reflux

Interventions

DRUG

Omeprazole, Lansoprazole, Esomeprazole, Rantidine

1.Omeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day 2.Lansoprazole-Dose range 15mg per day- 30mg twice a day 3.Esomeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day 4.Rantidine-Dose range: 150 mg twice a day or 300 mg

BEHAVIORAL

Voice therapy

Evaluation is completed over two, one-hour sessions. Once the evaluation is complete, the subject will begin weekly, individual voice therapy for 55 minute sessions per week with a second year graduate student under the direct supervision of the clinical faculty member.Treatment sessions will include a counseling component and an active exercise program.

OTHER

Combination of anti-reflux medication and voice therapy

Subjects will receive both anti-reflux medication as detailed above and voice therapy as detailed above.

Sponsors & Collaborators

  • Temple University

    lead OTHER

Principal Investigators

  • Nausheen Jamal, MD · Temple Hospital faculty member

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-08-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02530879 on ClinicalTrials.gov