Laryngeal and Vocal Tract Strategies to Reduce Vocal Fold Contact Pressure

NCT ID: NCT06165536

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2028-01-31

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.

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.

Conditions

Mid-membranous Vocal Fold Lesion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Resonant voice therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Zhaoyan Zhang, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaoyan Zhang

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA Rehab Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zhaoyan Zhang

Role: CONTACT

zyzhang@ucla.edu

3102064324

Facility Contacts

Zhaoyan Zhang

Role: primary

310-206-4324

Other Identifiers

R01DC020240

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-001058

Identifier Type: -

Identifier Source: org_study_id