An interventional study of exuberant voice therapy in Atrophy of Vocal Cord, Presbyphonia and Dysphonia, sponsored by University of Southern California. Not yet recruiting at 4 sites in United States. Open to participants aged 54 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
This study compares how well voice therapy works when delivered in-person versus through telehealth for older adults with age-related voice problems. Researchers are testing whether Phonation Resistance Training Exercises (PhoRTE®) can be just as effective when delivered remotely as when done face-to-face, which could make treatment more accessible and affordable for seniors.
The two primary hypotheses are:
Adults aged 55 or older with voice changes and an applicable diagnosis will be randomly assigned to receive either in-person or telehealth therapy, consisting of four 45-minute sessions. After treatment, researchers will measure improvements through:
The results will help determine if telehealth can be a good alternative to in-person voice therapy, especially important as telehealth coverage may be changing.
This study employs a prospective, noninferiority cohort design to compare the efficacy of in-person versus telehealth delivery of Phonation Resistance Training Exercises (PhoRTE®) for adults aged 55+ diagnosed with presbyphonia.
Participants will be recruited from the USC Voice Center, a multidisciplinary otolaryngology clinic with four outpatient locations in Southern California. Eligible participants must have a primary diagnosis of presbyphonia, age-related voice change, and/or vocal fold atrophy.
The study will use stratified block randomization with a 1:1 allocation ratio to ensure equitable distribution of severity across both treatment groups (in-person and telehealth). Electronic randomization algorithms will be implemented to mitigate selection bias.
Treatment Protocol:
Assessment Measures:
Validated patient-reported outcomes:
Expert clinical auditory/perceptual measures:
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) for voice quality and severity Note: Blinded independent evaluation by voice \& upper airways-specialized (VUAD) speech-language pathologists (minimum 5 years specialization in voice disorders with ≥80% voice disorder caseload) analysis of recorded voice samples
Instrumental acoustic/aerodynamic measures:
Data Collection Timeline:
Sample Size:
The target enrollment is 13-15 participants per treatment group (26-30 participants total), which aligns with previous research on PhoRTE® therapy for presbyphonia.
This protocol follows the tripartite model of evidence-based practice and therefore contains multiple primary outcomes through integration of patient-reported measures, clinical expertise, and instrumental assessment to comprehensively evaluate treatment efficacy across delivery modalities.
Exclusion Criteria:
PhoRTE® voice therapy will be administered to this treatment arm in-person (IP)(traditional therapy).
Behavioral: exuberant voice therapy
Study participants who will be receiving intervention via telehealth. Intervention administered will be PhoRTE® voice therapy.
Behavioral: exuberant voice therapy
exuberant voice therapy validated for patients with age-related voice changes (i.e., vocal fold atrophy, presbyphonia)
Also known as: Phonation Resistance Training Exercises (PhoRTE®)
Voice Handicap Index-10
5 point likert scale to assess voice-related quality of life impairment, where 0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always. 10 questions in total. Higher score indicates a greater voice handicap. Score of \>11 is considered abnormal. Measure will be collected at initial evaluation (baseline) and again following intervention (final evaluation).
Time frame: up to 16 weeks
Aging Voice Index
AVI Score at Baseline and re-evaluation. The Aging Voice Index (AVI) is a validated instrument that measures quality of life in older adults with voice disorders. A higher score indicates worse quality of life. Scores range from 0 to 92.
Time frame: up to 16 weeks
Voice Problem Impact Scales
A validated self assessment questionnaire in which the participant self-rates impact of voice on four domains of life on 1-7 likert scales (1. work/daily activities, 2. social life, 3. home life, 4. life overall.) Numbers are presented in equally appearing intervals with end anchors where 1=not at all affected and 7=profoundly. A higher score indicates higher degree of impact. Measure will be collected at initial evaluation (baseline) and again following intervention (final evaluation).
Time frame: up to 16 weeks
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
A validated auditory/perceptual voice quality and severity assessment tool to be used pre- and post-intervention. Blinded independent expert clinicians, identified as SLPs who have 5+ years of experience in the assessment and treatment of patients with voice disorders and who currently maintain a caseload of at least 80% voice patients, will assess recorded voice samples to describe participant voice quality and severity using the CAPE-V. Measure will be collected at initial evaluation (baseline) and again following intervention (final evaluation).
Time frame: up to 16 weeks
OMNI Vocal Effort Scale
Visual analog scale for patient-perceived vocal effort on a 0-10 scale where 0=extremely easy and 10=extremely hard. Patient is asked for perception of current voice effort during assessment and highest effort level experienced.
Time frame: up to 16 weeks
Acoustic Assessment: voicing intensity
Acoustic measure in sustained voicing via mean intensity (in dB SPL) and its standard deviation across a. standardized vowel /a/, b. standardized reading passage (Rainbow passage), and c. running, conversational speech. Measure will be collected at initial evaluation (baseline) and again following intervention (final evaluation).
Time frame: up to 16 weeks
Acoustic Assessment: Cepstral Peak Prominence
Acoustic measure in sustained voicing using Cepstral Peak Prominence and its standard deviation while reading a standardized passage (Rainbow passage). Measure will be collected at initial evaluation (baseline) and again following intervention (final evaluation).
Time frame: up to 16 weeks
Aerodynamic Measurement: phonatory airflow during speech
Airflow during voicing will be measured at baseline and again at final evaluation using the Phonatory Aerodynamic System Model 6600 (PAS; PENTAX Medical). Assessment includes flow during voicing across a. sustained vowel /a/ and running speech (first four sentences of standardized Rainbow Passage). The PAS reports airflow during voicing using a pneumotach with integrated facemask and external microphone. During voicing, pressure transducers on either side of the terminal collects and converts the air flow across time to determine airflow rate. The microphone captures the acoustic signal according to terminal-specific standardized calibration. Subjects maintain upright seated posture with the face mask firmly pressed to their face, ensuring an airtight seal over oral and nasal cavities during this task.
Time frame: up to 16 weeks
Aerodynamic Measurement: subglottal pressure
Subglottal pressure (Psub) will be measured at initial evaluation (baseline) and again at the conclusion of therapeutic intervention (final evaluation) using the Phonatory Aerodynamic System Model 6600 (PAS; PENTAX Medical). Assessment utilizes the valid labial interruption task via /pipipi/ syllable production task. The PAS collects intraoral pressure, which is a validated, non-invasive approximate to subglottal pressure. The participant thens produce the sequence at a comfortable pitch and loudness. Analysis then extracts the subglottal pressure by measuring airflow and intraoral pressure during speech.
Time frame: up to 16 weeks
Aerodynamic Measurement: phonation threshold pressure
Phonation threshold pressure (PTP) will be measured at initial evaluation (baseline) and again at the conclusion of therapeutic intervention (final evaluation) using the Phonatory Aerodynamic System Model 6600 (PAS; PENTAX Medical). Assessment utilizes the valid labial interruption task via /pipipi/ syllable production. PTP is the minimum subglottal pressure required to initiate and sustain vocal fold oscillation. The PAS collects intraoral pressure, which is a validated, non-invasive approximate to subglottal pressure. The participant thens produces the sequence at their softest vocal intensity. Analysis extracts the PTP by measuring the relationship between airflow and intraoral pressure at softest possible voicing.
Time frame: up to 16 weeks
Aerodynamic Measurement: number of breaths
mean number of breaths across a standardized reading passage (The Rainbow Passage) collected at baseline (initial evaluation) and once again after intervention (final evaluation).
Time frame: up to 16 weeks
duration across standardized reading passage
mean duration (in seconds) to complete the reading of a standard passage (The Rainbow Passage).
Time frame: up to 16 weeks
Plan to share: No — The number of resources and collaboration to collect and analyze the data is not feasible for the current research question and current available time and funding.
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