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

NCT07696429 | Completed

• 1 other identifier: Class No.8.1-19/31-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

High-Speed Digital Imaging; Topical Anesthesia; Lidocaine; Laryngopharyngeal Reflux; Phonation

Outcome Measures

Primary Outcomes (5)

• Change in Phonation Process Parameters Assessed by the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) Form

  Parameters assessed by visual-perceptual analysis of HSDI recordings using the VALI form: glottal sufficiency pattern, mucosal wave amplitude, free edge amplitude, vertical level of the vocal folds, non-vibrating segment of the vocal fold, supraglottic structure activation, free edge contour, open-to-closed phase ratio of the glottal cycle, phase symmetry of the vocal folds, periodicity, and axis shift of the vocal folds. Each recording was independently scored by two blinded raters, with discrepancies resolved by consensus.

  Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

• Change in Glottal Closure Pattern (European Laryngological Society Classification)

  Glottal closure pattern during the initial phase of the glottal cycle, classified according to the European Laryngological Society (ELS) form (e.g., concave, convex, straight, complex), assessed by visual-perceptual analysis of HSDI recordings.

  Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

• Change in Type of Glottal Insufficiency (European Laryngological Society Classification)

  Type of glottal insufficiency during phonation, classified according to a modified European Laryngological Society (ELS) classification (e.g., complete glottal closure, incomplete closure in the cartilaginous part of the glottis), assessed by visual-perceptual analysis of HSDI recordings.

  Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

• Change in Acoustic Voice Parameters (Fundamental Frequency and Phonation Intensity)

  Fundamental frequency (F0, Hz) and phonation intensity (dB) during phonation of the sustained vowel /a/, recorded via a microphone mounted on the endoscope with software processing.

  Assessed once per recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

• Change in Maximum Phonation Time (MPT)

  Maximum duration (seconds) of sustained, dynamically stationary phonation of the vowel /a/ following maximal inhalation, determined as the longest of three stopwatch-timed trials performed immediately before and after HSDI recording.

  Assessed immediately before and after each HSDI recording session; each participant recorded on 2 consecutive days (with and without topical anesthesia)

Study Arms (2)

Anesthesia-First Sequence (A→B)

EXPERIMENTAL

Participants received topical anesthesia (lidocaine spray, 100 mg/ml) applied to the base of the tongue, posterior pharyngeal wall, and soft palate on Day 1, followed by HSDI laryngoscopy 5 minutes later. On Day 2, the same participants received placebo (physiological saline), identically applied, followed by HSDI laryngoscopy. Order was determined by randomization.

Drug: Lidocaine 10% Spray; Drug: Placebo

Placebo-First Sequence (B→A)

PLACEBO COMPARATOR

Participants received placebo (physiological saline) applied to the base of the tongue, posterior pharyngeal wall, and soft palate on Day 1, followed by HSDI laryngoscopy 5 minutes later. On Day 2, the same participants received topical anesthesia (lidocaine spray, 100 mg/ml), identically applied, followed by HSDI laryngoscopy. Order was determined by randomization.

Drug: Lidocaine 10% Spray; Drug: Placebo

Interventions

Placebo DRUG

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.

Also known as: Normal saline spray; 0.9% NaCl spray

Anesthesia-First Sequence (A→B); Placebo-First Sequence (B→A)

Lidocaine 10% Spray DRUG

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.

Also known as: Xylocaine spray

Anesthesia-First Sequence (A→B); Placebo-First Sequence (B→A)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Newly diagnosed laryngopharyngeal reflux (LPR), defined as Reflux Symptom Index (RSI) \>13 and Reflux Finding Score (RFS) \>7 Age 18-45 years No prior HSDI recording Ability to tolerate HSDI examination without topical anesthesia

You may not qualify if:

• Known allergy to lidocaine and/or other allergens Acute respiratory infection within the preceding month Current smokers or regular alcohol consumers Chronic rhinosinusitis Prior surgery and/or radiotherapy of the larynx, neck, or thyroid gland Inability to visualize the full length of the vocal folds during the 2-second HSDI recording for anatomical reasons

Sponsors & Collaborators

• Mario Bilić: lead

Study Sites (1)

University Hospital Centre Zagreb (KBC Zagreb), Department of ORL Head and Neck Surgery

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Interventions

Lidocaine

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)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mario Bilić, prof. dr. sc. dr. med.

  Department of ORL Head and Neck Surgery, University Hospital Centre Zagreb, Croatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants were unaware of whether they received topical anesthesia or placebo on a given day. The physician administering the substance (lidocaine spray or placebo) was blinded to its identity. The two independent assessors performing visual-perceptual analysis of the HSDI recordings were blinded to the treatment assignment for each recording.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Mario Bilić, MD, PhD Head of the Department of Head and Neck Tumors Department of Otorhinolaryngology and Head and Neck Surgery University Hospital Centre Zagreb, Zagreb, Croatia

Model Details: Two-period, two-sequence crossover design. Each participant underwent HSDI laryngoscopy on two consecutive days, receiving topical anesthesia (lidocaine spray) on one day and placebo (physiological saline) on the other. Sequence order was determined by randomization (even-numbered participants: anesthesia first; odd-numbered: placebo first) and could not be altered once assigned.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: March 1, 2019
• Primary Completion: January 5, 2021
• Study Completion: December 5, 2021
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)