Comparison of Voice Therapy and Antireflex Therapy in LPR
Withdrawn before enrolling · Phase 4
Conditions studied: Laryngopharyngeal Reflux
In brief
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.
Key facts
- Study ID
- NCT02530879
- Run by
- Temple University
- People needed
- 0
- Starts
- 2016-05-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2018-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 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.
Where it is running
- Temple Otolaryngology — Philadelphia, Pennsylvania, United States
- Temple University Hospital — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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