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Comparison of Voice Therapy and Antireflex Therapy in LPR

Primary Purpose

Laryngopharyngeal Reflux

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omeprazole, Lansoprazole, Esomeprazole, Rantidine
Voice therapy
Combination of anti-reflux medication and voice therapy
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngopharyngeal Reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Temple Otolaryngology
  • Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Voice therapy

Antireflux medication

Voice therapy and Anti-reflux therapy

Arm Description

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.

Intervention includes treatment with one of the following: Omeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day Lansoprazole-Dose range 15mg per day- 30mg twice a day Esomeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day Rantidine-Dose range: 150 mg twice a day or 300 mg once a day. Rantidine may be used in combination with any of the above

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

Outcomes

Primary Outcome Measures

Comparison of pre and post treatment voice outcomes in LPR-related dysphonia based on pre and post treatment CAPE-V Scores
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
Comparison of treatment outcomes in laryngeal reflux findings based on RFS scores
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.
Comparison of treatment outcomes in laryngeal reflux symptoms based on RSI scores
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.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2015
Last Updated
May 15, 2018
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT02530879
Brief Title
Comparison of Voice Therapy and Antireflex Therapy in LPR
Official Title
Comparison of Voice Therapy and Antireflex Therapy in the Treatment of Laryngopharyngeal Reflux-related Hoarseness: A Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Inability to recruit patients
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Voice therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Antireflux medication
Arm Type
Active Comparator
Arm Description
Intervention includes treatment with one of the following: Omeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day Lansoprazole-Dose range 15mg per day- 30mg twice a day Esomeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day Rantidine-Dose range: 150 mg twice a day or 300 mg once a day. Rantidine may be used in combination with any of the above
Arm Title
Voice therapy and Anti-reflux therapy
Arm Type
Experimental
Arm Description
Subjects will receive both anti-reflux medication as detailed above and voice therapy as detailed above.
Intervention Type
Drug
Intervention Name(s)
Omeprazole, Lansoprazole, Esomeprazole, Rantidine
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Combination of anti-reflux medication and voice therapy
Intervention Description
Subjects will receive both anti-reflux medication as detailed above and voice therapy as detailed above.
Primary Outcome Measure Information:
Title
Comparison of pre and post treatment voice outcomes in LPR-related dysphonia based on pre and post treatment CAPE-V Scores
Description
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
Time Frame
3 months
Title
Comparison of treatment outcomes in laryngeal reflux findings based on RFS scores
Description
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.
Time Frame
3 months
Title
Comparison of treatment outcomes in laryngeal reflux symptoms based on RSI scores
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nausheen Jamal, MD
Organizational Affiliation
Temple Hospital faculty member
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple Otolaryngology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with participants at the completion of the 3 month study period
Citations:
PubMed Identifier
23124925
Citation
Fusconi M, De Virgilio A, Conte M, Colicchio MG, Gallo A, Greco A, Ralli G, de Vincentiis M. The importance of the number of reflux episodes in the diagnosis of laryngopharyngeal reflux disease. Otolaryngol Head Neck Surg. 2013 Feb;148(2):261-6. doi: 10.1177/0194599812466534. Epub 2012 Nov 2.
Results Reference
background
PubMed Identifier
12512644
Citation
Hicks DM, Ours TM, Abelson TI, Vaezi MF, Richter JE. The prevalence of hypopharynx findings associated with gastroesophageal reflux in normal volunteers. J Voice. 2002 Dec;16(4):564-79. doi: 10.1016/s0892-1997(02)00132-7.
Results Reference
background
PubMed Identifier
12161727
Citation
Koufman JA, Aviv JE, Casiano RR, Shaw GY. Laryngopharyngeal reflux: position statement of the committee on speech, voice, and swallowing disorders of the American Academy of Otolaryngology-Head and Neck Surgery. Otolaryngol Head Neck Surg. 2002 Jul;127(1):32-5. doi: 10.1067/mhn.2002.125760. No abstract available.
Results Reference
result
PubMed Identifier
16481828
Citation
Karkos PD, Wilson JA. Empiric treatment of laryngopharyngeal reflux with proton pump inhibitors: a systematic review. Laryngoscope. 2006 Jan;116(1):144-8. doi: 10.1097/01.mlg.0000191463.67692.36.
Results Reference
result
PubMed Identifier
21908799
Citation
Park JO, Shim MR, Hwang YS, Cho KJ, Joo YH, Cho JH, Nam IC, Kim MS, Sun DI. Combination of voice therapy and antireflux therapy rapidly recovers voice-related symptoms in laryngopharyngeal reflux patients. Otolaryngol Head Neck Surg. 2012 Jan;146(1):92-7. doi: 10.1177/0194599811422014. Epub 2011 Sep 9.
Results Reference
result

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Comparison of Voice Therapy and Antireflex Therapy in LPR

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