Comparison of Voice Therapy and Antireflex Therapy in LPR

NCT02530879 | Withdrawn Phase 4

• 1 other identifier: 22455
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Laryngopharyngeal Reflux

Outcome Measures

Primary Outcomes (3)

• 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

  3 months

• 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.

  3 months

• 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.

  3 months

Study Arms (3)

Voice therapy

EXPERIMENTAL

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

Antireflux medication

ACTIVE COMPARATOR

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

Voice therapy and Anti-reflux therapy

EXPERIMENTAL

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

Interventions

Omeprazole, Lansoprazole, Esomeprazole, Rantidine DRUG

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

Antireflux medication

Voice therapy BEHAVIORAL

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.

Voice therapy

Combination of anti-reflux medication and voice therapy OTHER

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

Voice therapy and Anti-reflux therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Hoarseness
• Reflux symptom index score \>13
• Reflux finding score \>7
• English speaking

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead

Study Sites (2)

Temple Otolaryngology

Philadelphia, Pennsylvania, 19140, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (5)

• 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.

  PMID: 23124925 BACKGROUND

• 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.

  PMID: 12512644 BACKGROUND

• 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.

  PMID: 12161727 RESULT

• 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.

  PMID: 16481828 RESULT

• 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.

  PMID: 21908799 RESULT

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Interventions

Omeprazole; Lansoprazole; Esomeprazole

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nausheen Jamal, MD

  Temple Hospital faculty member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 21, 2015
• Study Start: May 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)