Laryngeal and Vocal Tract Strategies to Reduce Vocal Fold Contact Pressure

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.

Study Overview

• Status: Recruiting
• Conditions: Mid-membranous Vocal Fold Lesion
• Intervention / Treatment: Behavioral: Resonant voice therapy

Detailed Description

This study will investigate the degree to which a well-documented voice therapy technique, resonant voice therapy, reduces vocal fold contact pressure compared to baseline, and which if any laryngeal and vocal tract adjustments occur in association with this phonation pattern. The investigators will measure contact pressure in vivo in human subjects, and will use computed tomography scans to assess laryngeal and vocal tract configurations before and after initial voice training, in adults with phonotraumatic lesions. The investigators will correlate these measures to patient-reported outcome measures and other secondary outcome measures across longer-term therapy. It is hypothesized that findings regarding favorable physical adjustments associated with reduction in contact pressure shown in this aim will match those identified in our recent simulation studies, and that initial reduction in contact pressure in resonant voice, associated with relevant perceptual, acoustic, and subglottic pressure changes, will correlate with improved long-term voice therapy outcome.

Patients will be those who have been diagnosed by a fellowship trained laryngologist with bilateral mid-membranous lesions that by appearance and history are phonotraumatic and who are referred to resonant voice therapy (RVT). Each subject will receive resonant voice therapy, 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. All voice therapy sessions will be video recorded. Ten percent of recordings will be randomly selected and used in fidelity checks. Data collection will take place at 3 time points: before therapy (baseline), immediately after an initial therapy session, and after 4 weeks of therapy. At baseline, each subject will fill out a Voice Handicap Index-10 (VHI-10) questionnaire, and will receive videoendoscopic examination, CT scans of the head and neck region during phonation, acoustic and subglottal pressure measurement, and contact pressure measurement. Data collection will be repeated the same day following an initial session of RVT training. Same-day data collection will ensure that lesion characteristics have not changed from baseline, and avoid confounding effects of lesion change in contact pressure measures. Degree of resonant voice acquisition will be determined by speech language pathologists (SLPs) real-time and will be further characterized quantitatively by post hoc perceptual evaluation and acoustic measures. Finally, after 4 weeks of RVT, follow-up measure will include VHI-10, endoscopic exam, perceptual, acoustic, and subglottal pressure measurement.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaoyan Zhang; Phone Number: 3102064324; Email: zyzhang@ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Rehab Center
      • Contact: Zhaoyan Zhang; Phone Number: 310-206-4324
      • Principal Investigator: Zhaoyan Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Voice therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptual evaluation of voice	Perceptual evaluation will be conducted on the recorded phrase, "We were away a year ago," using the Overall Severity scale from the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V), using pre-post therapy paired comparison procedures. Scores will range between 0 and 100, with higher scores indicating worse outcomes. Raters will be five blinded voice-specialized speech language pathologists otherwise not involved with the study.	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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Zhaoyan Zhang, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Vocal fold lesion; Vocal hyperfunction
• Other Study ID Numbers: 22-001058; R01DC020240 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data collected during this project, including acoustic, aerodynamic, vocal fold geometry data from medial surface imaging or CT scans, vocal fold contact pressure, will be archived and made available to interested investigators on request after the investigators have finished planned analyses and publications.
• IPD Sharing Time Frame: After the investigators have finished planned analyses and publications
• IPD Sharing Access Criteria: Data will be made available to interested investigators upon request to and reviewed by the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No