PhoRTE® Therapy Efficacy: In-Person Versus Telehealth

January 9, 2026 updated by: Aaron Rothbart, PhD, University of Southern California

Phonation Resistance Training Exercises (PhoRTE®) Delivered In-person and Via Telehealth: A Noninferiority Randomized Clinical Trial

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:

  1. Does voice therapy (called PhoRTE®) work as well through video calls as it does face-to-face?
  2. Can online therapy be a more accessible way for older adults to get help for their voice problems?

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:

  • Changes in voice function
  • Patient reports about their voice
  • Scientific measurements of voice quality
  • Patient satisfaction with treatment
  • Impact on quality of life

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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:

  • Both groups will complete four 45-minute sessions of voice therapy
  • Sessions will be conducted at weekly or biweekly intervals
  • PhoRTE® therapeutic intervention involves exuberant vocalization techniques utilizing high-intensity phonation with expanded oral aperture configuration ("megaphone mouth shape") to optimize phonatory efficiency and augment vocal intensity without inducing vocal strain/hyperfunction

Assessment Measures:

  1. Validated patient-reported outcomes:

    1. Voice Handicap Index-10 (VHI-10) for quantification of perceived voice-related quality of life impairment
    2. Aging Voice Index (AVI) for quantification of perceived voice-related quality of life impairment for aging populations
    3. OMNI-Vocal Effort Scale for perceived assessment of effort with voicing
    4. Voice Problem Impact Scales (VPIS) for multidimensional evaluation of voice-related quality of life

  2. 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

  3. Instrumental acoustic/aerodynamic measures:

    1. Acoustic measures: cepstral peak prominence (CPP), CPP standard deviation (CPP SD), fundamental frequency (fo), and vocal intensity/loudness (dB SPL) in sustained vowels and connected speech - Aerodynamic measures: subglottal pressure (Psub), phonation threshold pressure (PTP), and mean airflow during voicing with corresponding duration and number of replenishing breaths during sustained vowels and connected speech

Data Collection Timeline:

  • Baseline measures will be obtained at the initial interprofessional evaluation
  • Post-intervention evaluations will occur one week after the terminal therapeutic session
  • All measurement parameters will be repeated at both timepoints to assess treatment effects

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Arcadia, California, United States, 91007
      • Beverly Hills, California, United States, 90211
      • Glendale, California, United States, 91204
        • USC Voice Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Alexandra Chace Purdy, BM, MA CF-SLP
        • Sub-Investigator:
          • Maria Eugenia Castro, MS CCC-SLP
      • Los Angeles, California, United States, 90033
        • USC Voice Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kacie La Forest, MA CCC-SLP
        • Sub-Investigator:
          • Felicia François, MS CCC-SLP
        • Sub-Investigator:
          • Alexandra Chace Purdy, BM, MA CF-SLP
        • Sub-Investigator:
          • Maria Eugenia Castro, MS CCC-SLP
        • Sub-Investigator:
          • Lauren Timmons Sund, BM, MS CCC-SLP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 55+ with a primary diagnosis of presbyphonia, age-related voice changes, and/or vocal fold atrophy with or without localized loss of lamina propria (e.g. vocal fold scar)
  • Telehealth-capable device (e.g., tablet, computer) with microphone, speaker, camera, high-speed internet
  • Ability to attend four telehealth or in-person sessions for four consecutive sessions
  • Ability to attend two in-person evaluation sessions (pre- and post-treatment)

Exclusion Criteria:

  • Presence of localized masses, lesions, or vocal fold motion impairments identified during videostroboscopy at initial evaluation
  • Progressive neurologic conditions, e.g. Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS), Progressive supranuclear palsy (PSP), etc.
  • Previous attendance to exuberant voice therapy (e.g., PhoRTE, Lee Silverman Voice Treatment)
  • Untreated hearing loss
  • Non-English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PhoRTE - IP
PhoRTE® voice therapy will be administered to this treatment arm in-person (IP)(traditional therapy).
Behavioral: exuberant voice therapy
exuberant voice therapy validated for patients with age-related voice changes (i.e., vocal fold atrophy, presbyphonia)
Other Names:
  • Phonation Resistance Training Exercises (PhoRTE®)
Experimental: PhoRTE - TH
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)
Other Names:
  • Phonation Resistance Training Exercises (PhoRTE®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice Handicap Index-10
Time Frame: up to 16 weeks
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).
up to 16 weeks
Aging Voice Index
Time Frame: up to 16 weeks
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.
up to 16 weeks
Voice Problem Impact Scales
Time Frame: up to 16 weeks

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).
up to 16 weeks
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Time Frame: up to 16 weeks

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).
up to 16 weeks
OMNI Vocal Effort Scale
Time Frame: up to 16 weeks
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.
up to 16 weeks
Acoustic Assessment: voicing intensity
Time Frame: up to 16 weeks

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).
up to 16 weeks
Acoustic Assessment: Cepstral Peak Prominence
Time Frame: up to 16 weeks

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).
up to 16 weeks
Aerodynamic Measurement: phonatory airflow during speech
Time Frame: up to 16 weeks

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.
up to 16 weeks
Aerodynamic Measurement: subglottal pressure
Time Frame: up to 16 weeks

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.
up to 16 weeks
Aerodynamic Measurement: phonation threshold pressure
Time Frame: up to 16 weeks

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.
up to 16 weeks
Aerodynamic Measurement: number of breaths
Time Frame: up to 16 weeks
mean number of breaths across a standardized reading passage (The Rainbow Passage) collected at baseline (initial evaluation) and once again after intervention (final evaluation).
up to 16 weeks
duration across standardized reading passage
Time Frame: up to 16 weeks
mean duration (in seconds) to complete the reading of a standard passage (The Rainbow Passage).
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Aaron Rothbart, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

October 25, 2026

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP-24-06117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on exuberant voice therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe