Comparison of Voice Therapy and Antireflex Therapy in LPR

May 15, 2018 updated by: Temple University

Comparison of Voice Therapy and Antireflex Therapy in the Treatment of Laryngopharyngeal Reflux-related Hoarseness: A Prospective Randomized Control Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hoarseness is one of the most common presenting complaints in otolaryngology. The differential diagnosis for hoarseness is board, but a large percentage has been attributed to laryngopharyngeal reflux (LPR). LPR refers to the symptomatic effects of regurgitated gastric contents into the pharynx and larynx.1-3 1,2 Although dual-probe 24 hour pH monitoring is the gold standard in the diagnosis of LPR, it is not always performed due to inconvenience and cost. Patients are commonly treated based on history and physical examination findings alone. The literature on the efficacy of anti-reflux therapy and LPR is controversial. Karkos et al performed a systematic review on the use of empiric treatment of proton pump inhibitors (PPI) in patients suspected of having LPR and found no statistically significant difference between patients treated with PPI and those treated with placebo in reference to symptom severity or frequency of presumed reflux events. 2 Commonly patients are started on empiric therapy with anti-reflux medications and lifestyle modifications. Laryngoscopy is performed on all patients presenting with dysphonia. While a variety of findings have been characterized as consistent with reflux a study performed by Hicks et al, found that 86% of normal volunteers had findings consistent with reflux on flexible laryngoscopy.5 This calls into question the sensitivity and specificity of laryngoscopy in the diagnosis of LPR. Park et al performed a study comparing the effectiveness of anti-reflux therapy alone versus a combination of voice therapy with PPI in the treatment of presumed LPR-related dysphonia, and found combination therapy to be superior to anti-reflux therapy alone. 3 Because there are no studies comparing voice therapy directly with anti-reflux therapy, one cannot determine whether the improvements are due to augmentation of anti-reflux therapy with voice therapy, or if voice therapy alone is superior in the treatment of LPR-related dysphonia. There are currently no studies comparing the effectiveness of voice therapy alone, anti-reflux therapy alone, and combination therapy. Patients who present with dysphonia may be over treated with anti-reflux medications. These medications are not without side effects. It is hypothesized that a subset of patients who are thought to have reflux related dysphonia are misusing their voice and can be successfully treated with voice therapy alone. This study will be a prospective, randomized, unblinded but controlled trial. Patients presenting to the Otolaryngology clinic who are diagnosed with LPR-related dysphonia who meet inclusion criteria will be eligible to enroll in the study and will be randomized to one of the three treatment arms. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple Otolaryngology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Active Comparator: Antireflux medication

Intervention includes treatment with one of the following:

  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 once a day.
  5. Rantidine may be used in combination with any of the above
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
Experimental: Voice therapy and Anti-reflux therapy
Subjects will receive both anti-reflux medication as detailed above and voice therapy as detailed above.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of pre and post treatment voice outcomes in LPR-related dysphonia based on pre and post treatment CAPE-V Scores
Time Frame: 3 months
Voice outcomes in patients with LPR related dysphonia treated with voice therapy, anti-reflux therapy, or a combination will be compared based on consensus auditory perceptual evaluation-voice scores
3 months
Comparison of treatment outcomes in laryngeal reflux findings based on RFS scores
Time Frame: 3 months
Reflux finding scores based on laryngoscopy findings will be obtained at the beginning of the study and after treatment. Subjects treated with voice therapy, anti-reflux medication, or a combination will be compared.
3 months
Comparison of treatment outcomes in laryngeal reflux symptoms based on RSI scores
Time Frame: 3 months
Reflux symptom index is a questionnaire subjects will fill out before the study and after treatment. Subjects treated with voice therapy, anti-reflux medication, or a combination will be compared.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Temple University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nausheen Jamal, MD, Temple Hospital faculty member

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be shared with participants at the completion of the 3 month study period

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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