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Effect of Topical Anesthesia on the Phonation Process During High-Speed Digital Imaging Laryngoscopy in Patients With Laryngopharyngeal Reflux

NCT07696429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-07-10

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if topical anesthesia (lidocaine spray) affects the phonation process during High-Speed Digital Imaging (HSDI) laryngoscopy in adults with laryngopharyngeal reflux (LPR). The main questions it aims to answer are:

Does topical anesthesia change phonation process parameters (such as mucosal wave amplitude, glottal closure pattern, phase symmetry, and periodicity) as assessed on the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form? Does topical anesthesia change the type of glottal insufficiency observed during phonation?

Researchers will compare HSDI recordings performed with topical anesthesia (lidocaine spray) to recordings performed with placebo (physiological saline) to see if topical anesthesia alters phonation process findings.

Participants will:

Undergo HSDI laryngoscopy recording on two consecutive days, once with topical anesthesia and once with placebo, in a randomized, double-blind order Have a detailed medical history taken and complete the Reflux Symptom Index (RSI) questionnaire Undergo fiberendoscopic examination for determination of the Reflux Finding Score (RFS) Return for a follow-up examination within three months, during which they will continue proton pump inhibitor therapy and hygienic-dietary measures

Conditions

  • Laryngo-pharyngeal Reflux

Interventions

DRUG

Lidocaine 10% Spray

Lidocaine spray, 100 mg/ml, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment.

DRUG

Placebo

Physiological saline (0.9% NaCl) spray, administered topically as one actuation (0.1 ml) each to the base of the tongue, posterior pharyngeal wall, and soft palate, approximately 5 minutes prior to HSDI laryngoscopy. Administered once per participant, on one of the two study days according to randomized sequence assignment, identical in application technique to the lidocaine intervention.

Sponsors & Collaborators

  • Mario Bilić

    lead OTHER

Principal Investigators

  • Mario Bilić, prof. dr. sc. dr. med. · Department of ORL Head and Neck Surgery, University Hospital Centre Zagreb, Croatia

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-01-05
Completion
2021-12-05

Countries

  • Croatia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696429 on ClinicalTrials.gov