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Comparison of Voice Therapy and Antireflex Therapy in LPR

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ClinicalTrials.gov Identifier: NCT02530879
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Laryngopharyngeal Reflux Drug: Omeprazole, Lansoprazole, Esomeprazole, Rantidine Behavioral: Voice therapy Other: Combination of anti-reflux medication and voice therapy Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Voice Therapy and Antireflex Therapy in the Treatment of Laryngopharyngeal Reflux-related Hoarseness: A Prospective Randomized Control Trial
Study Start Date : May 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530879


Contacts
Contact: Nausheen Jamal, MD 215-707-3665 nausheen.jamal@tuhs.temple.edu
Contact: Rachel Georgopoulos, MD 267-838-0609 rachel.georgopoulos@tuhs.temple.edu

Locations
United States, Pennsylvania
Temple Otolaryngology Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Rachel A Georgopoulos, MD    267-838-0609    hoarsenessstudy@gmail.com   
Principal Investigator: Nausheen Jamal, MD         
Sub-Investigator: Ahmed Soliman, MD         
Sub-Investigator: Ann Addis, MA, CCC-SLP         
Sub-Investigator: Rachel Georgopoulos, MD         
Temple University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nausheen Jamal, MD    215-707-3665    nausheen.jamal@tuhs.temple.edu   
Contact: Ahmed Soliman, MD    215-707-3665    asoliman@temple.edu   
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Nausheen Jamal, MD Temple Hospital faculty member
More Information

Publications:
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT02530879     History of Changes
Other Study ID Numbers: 22455
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with participants at the completion of the 3 month study period

Additional relevant MeSH terms:
Laryngopharyngeal Reflux
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Omeprazole
Esomeprazole
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action