Laryngeal and Vocal Tract Strategies to Reduce Vocal Fold Contact Pressure

NCT06165536 | Recruiting

• 2 other identifiers: 22-001058R01DC020240
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Phonotraumatic vocal hyperfunction is one of the most frequently occurring conditions to affect the voice. This voice disorder often involves vocal fold injury due to repeated, excessive contact pressure between the vocal folds when they collide during voice production. In the clinic, voice therapy attempts to modify unhealthy vocal behaviors through different techniques or exercises. While voice therapy is generally considered effective, the scientific rationale for its therapeutic benefits still remains unclear. It is generally believed that these exercises lead to adjustments in the larynx and vocal tract that reduce vocal fold contact pressure. However, this assumption has never been tested in humans or laboratory experiments. The goal of this clinical trial is to investigate the effectiveness of voice therapy in reducing vocal fold contact pressures and in eliciting the hypothesized favorable laryngeal and vocal tract configurations.

Conditions

Mid-membranous Vocal Fold Lesion

Keywords

Vocal fold lesion; Vocal hyperfunction

Outcome Measures

Primary Outcomes (2)

• Voice handicap index (VHI-10)

  VHI-10 scores will be measured using the voice handicap index-10 questionnaire. Scores for the VHI-10 range from 0 to 40, with higher scores indicating a greater voice-related handicap.

  30 minutes before the first voice therapy session, and 30 minutes after the last session of the 4-week voice therapy

• Severity of vocal fold lesions

  The medical severity of vocal fold lesions will be rated based on videoendoscopic examination of the larynx. The Nuss scale - a vetted, widely clinically used visual-perceptual scale - will be used to rate presence/absence of nodules (0) and nodules size (1 = small, 2 = moderate, 3 = large). Higher scores indicate worse outcomes.

  30 minutes before the first voice therapy session, and 30 minutes after the last session of the 4-week voice therapy

Secondary Outcomes (1)

• Perceptual evaluation of voice

  Perceptual evaluation will be performed within 6 months of data collection, using voices recorded 30 minutes before and 30 minutes after the first voice therapy session and 30 minutes after the last session of the 4-week voice therapy

Study Arms (1)

Voice therapy

OTHER

Resonant voice therapy is a standard of care procedure for treating phonotraumatic vocal hyperfunction. The full standardized voice therapy program will have a duration of four weeks, each week with one 60-minute therapy session.

Behavioral: Resonant voice therapy

Interventions

Resonant voice therapy BEHAVIORAL

Resonant voice therapy is a standard of care procedure for treating phonotraumatic vocal hyperfunction. The full standardized voice therapy program will have a duration of four weeks, each week with one 60-minute therapy session.

Voice therapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-40 years (to minimize developmental changes associated with adolescent and elderly age)
• Clinic diagnosis by a fellowship trained laryngologist of mid-membranous lesions that by history and appearance are phonotraumatic
• Must be referred for voice therapy

You may not qualify if:

• Medical comorbidities (e.g., autoimmune disorders) beyond seasonal allergy and laryngopharyngeal reflux
• Vocal fold lesions generally regarded to be less responsive to voice therapy (e.g. vocal fold cysts).
• Claustrophobia
• Inability to replicate fundamental frequencies required for the study at the intensity levels determined

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• University of California, Los Angeles: lead

Study Sites (1)

UCLA Rehab Center

Los Angeles, California, 90095, United States

RECRUITING

Study Officials

• Zhaoyan Zhang

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoyan Zhang

CONTACT

3102064324; zyzhang@ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 11, 2023
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After the investigators have finished planned analyses and publications
• Access Criteria: Data will be made available to interested investigators upon request to and reviewed by the principal investigator.

Locations

US (1)