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Atrophy of Vocal CordNCT06934265

PhoRTE® Therapy Efficacy: In-Person Versus Telehealth

A study testing exuberant voice therapy in people with Atrophy of Vocal Cord and Presbyphonia, run by University of Southern California at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 54 years and older
Conditions the study is for
Atrophy of Vocal Cord, Presbyphonia, Dysphonia
What is being tested?
exuberant voice therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
4 sitesUnited States
Study dates
25 Jan 2026to 25 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 54 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alexandra Chace Purdy, BM, MA contact

607 592-9123

alexcptheslp@gmail.com

M. Eugenia Castro, MS CCC-SLP contact

(323) 833-4530

mariaeugenia.castro@med.usc.edu

United States4 sites

  • USC Voice Center

    Arcadia, California, 91007

    Alexandra Chace Purdy, BM, MA CF-SLP, 323-442-5790, alexandra.chacepurdy@med.usc.edu

    Maria Eugenia Castro, MS CCC-SLP, 323-442-5790, mariaeugenia.castro@med.usc.edu

  • USC Voice Center

    Beverly Hills, California, 90211

    Alexandra Chace Purdy, BM, MA CF-SLP, (310) 601-3367, alexandra.chacepurdy@med.usc.edu

    Maria Eugenia Castro, MS CCC-SLP, (310) 601-3367, mariaeugenia.castro@med.usc.edu

  • USC Voice Center

    Glendale, California, 91204

    Alexandra Chace Purdy, BM, MA CF-SLP, (818) 507 9115, alexandra.chacepurdy@med.usc.edu

    Maria Eugenia Castro, MS CCC-SLP, (818) 507 9115, mariaeugenia.castro@med.usc.edu

  • USC Voice Center

    Los Angeles, California, 90033

    Alexandra Chace Purdy, BM, MA CF-SLP, 323-442-5790, alexandra.chacepurdy@med.usc.edu

    Lauren Timmons Sund, BM, MS, CCC-SLP, 323-442-5790, lauren.timmonssund@med.usc.edu

Other trials in United States

About this study

Official title: 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:

Read more
  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.

Read the 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:
  2. Voice Handicap Index-10 (VHI-10) for quantification of perceived voice-related quality of life impairment
  3. Aging Voice Index (AVI) for quantification of perceived voice-related quality of life impairment for aging populations
  4. OMNI-Vocal Effort Scale for perceived assessment of effort with voicing
  5. Voice Problem Impact Scales (VPIS) for multidimensional evaluation of voice-related quality of life
  6. 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
  7. Instrumental acoustic/aerodynamic measures:
  8. 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.

Being tested
exuberant voice therapy
Keywords
Vocal fold atrophy, voice therapy, presbyphonia, aging voice, voice rehabilitation, speech pathology, Intervention, voice, aging
Medical subject headings
Dysphonia, Voice Disorders, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exuberant voice therapyBehavioural

    Also called Phonation Resistance Training Exercises (PhoRTE®)

    exuberant voice therapy validated for patients with age-related voice changes (i.e., vocal fold atrophy, presbyphonia)

Study groups in NCT06934265
Study groupRoleWhat they receive
PhoRTE - IPActive comparatorPhoRTE® voice therapy will be administered to this treatment arm in-person (IP)(traditional therapy).
Receives: Behavioral: exuberant voice therapy
PhoRTE - THExperimentalStudy participants who will be receiving intervention via telehealth. Intervention administered will be PhoRTE® voice therapy.
Receives: Behavioral: exuberant voice therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: up to 16 weeks

  2. 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.

    Measured: up to 16 weeks

  3. 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).

    Measured: up to 16 weeks

  4. 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).

    Measured: up to 16 weeks

  5. 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.

    Measured: up to 16 weeks

  6. 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).

    Measured: up to 16 weeks

  7. 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).

    Measured: up to 16 weeks

  8. 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.

    Measured: up to 16 weeks

  9. 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.

    Measured: up to 16 weeks

  10. 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.

    Measured: up to 16 weeks

  11. 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).

    Measured: up to 16 weeks

  12. duration across standardized reading passage

    mean duration (in seconds) to complete the reading of a standard passage (The Rainbow Passage).

    Measured: up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start25 Jan 2026 (estimated)
  3. Primary completion25 Jul 2026 (estimated)
  4. Study completion25 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Each group will get the same intervention; however, delivery method will differ (in-person vs telehealth-delivered)
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06934265
Sponsor's protocol ID
APP-24-06117
Status last verified
Jan 2026
First submitted
11 Mar 2025
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Shoffel-Havakuk H, Marks KL, Morton M, Johns MM 3rd, Hapner ER. Validation of the OMNI vocal effort scale in the treatment of adductor spasmodic dysphonia. Laryngoscope. 2019 Feb;129(2):448-453. doi: 10.1002/lary.27430. Epub 2018 Oct 12.

    PubMed 30315575

  • Galluzzi F, Garavello W. The aging voice: a systematic review of presbyphonia. Eur Geriatr Med. 2018 Oct;9(5):559-570. doi: 10.1007/s41999-018-0095-6. Epub 2018 Sep 3.

    PubMed 34654233

  • Desjardins M, Halstead L, Simpson A, Flume P, Bonilha HS. Respiratory Muscle Strength Training to Improve Vocal Function in Patients with Presbyphonia. J Voice. 2022 May;36(3):344-360. doi: 10.1016/j.jvoice.2020.06.006. Epub 2020 Jul 14.

    PubMed 32680804

  • Lindstrom E, Ohlund Wistbacka G, Lotvall A, Rydell R, Lyberg Ahlander V. How older adults relate to their own voices: a qualitative study of subjective experiences of the aging voice. Logoped Phoniatr Vocol. 2023 Dec;48(4):163-171. doi: 10.1080/14015439.2022.2056243. Epub 2022 Apr 21.

    PubMed 35446741

  • Ziegler A, Verdolini Abbott K, Johns M, Klein A, Hapner ER. Preliminary data on two voice therapy interventions in the treatment of presbyphonia. Laryngoscope. 2014 Aug;124(8):1869-76. doi: 10.1002/lary.24548. Epub 2014 Jan 29.

    PubMed 24375313

  • Guglani I, Sanskriti S, Joshi SH, Anjankar A. Speech-Language Therapy Through Telepractice During COVID-19 and Its Way Forward: A Scoping Review. Cureus. 2023 Sep 6;15(9):e44808. doi: 10.7759/cureus.44808. eCollection 2023 Sep.

    PubMed 37809138

  • Griffin M, Bentley J, Shanks J, Wood C. The effectiveness of Lee Silverman Voice Treatment therapy issued interactively through an iPad device: A non-inferiority study. J Telemed Telecare. 2018 Apr;24(3):209-215. doi: 10.1177/1357633X17691865. Epub 2017 Feb 1.

    PubMed 28147896

  • Theodoros DG, Hill AJ, Russell TG. Clinical and Quality of Life Outcomes of Speech Treatment for Parkinson's Disease Delivered to the Home Via Telerehabilitation: A Noninferiority Randomized Controlled Trial. Am J Speech Lang Pathol. 2016 May 1;25(2):214-32. doi: 10.1044/2015_AJSLP-15-0005.

    PubMed 27145396

  • Titze IR, Palaparthi A, Cox K, Stark A, Maxfield L, Manternach B. Vocalization with semi-occluded airways is favorable for optimizing sound production. PLoS Comput Biol. 2021 Mar 29;17(3):e1008744. doi: 10.1371/journal.pcbi.1008744. eCollection 2021 Mar.

    PubMed 33780433

  • Belsky MA, Shelly S, Rothenberger SD, Ziegler A, Hoffman B, Hapner ER, Gartner-Schmidt JL, Gillespie AI. Phonation Resistance Training Exercises (PhoRTE) With and Without Expiratory Muscle Strength Training (EMST) For Patients With Presbyphonia: A Noninferiority Randomized Clinical Trial. J Voice. 2023 May;37(3):398-409. doi: 10.1016/j.jvoice.2021.02.015. Epub 2021 Mar 16.

    PubMed 33741235

  • Kempster GB, Gerratt BR, Verdolini Abbott K, Barkmeier-Kraemer J, Hillman RE. Consensus auditory-perceptual evaluation of voice: development of a standardized clinical protocol. Am J Speech Lang Pathol. 2009 May;18(2):124-32. doi: 10.1044/1058-0360(2008/08-0017). Epub 2008 Oct 16.

    PubMed 18930908

  • Castro ME, Sund LT, Hoffman MR, Hapner ER. The Voice Problem Impact Scales (VPIS). J Voice. 2024 May;38(3):666-673. doi: 10.1016/j.jvoice.2021.11.011. Epub 2021 Dec 20.

    PubMed 34933795

  • Rosen CA, Lee AS, Osborne J, Zullo T, Murry T. Development and validation of the voice handicap index-10. Laryngoscope. 2004 Sep;114(9):1549-56. doi: 10.1097/00005537-200409000-00009.

    PubMed 15475780

Questions about this trial

What is this clinical trial studying?

A study testing exuberant voice therapy in people with Atrophy of Vocal Cord and Presbyphonia, run by University of Southern California at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexandra Chace Purdy, BM, MA (607 592-9123, alexcptheslp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Voice Handicap Index-10 (time frame: up to 16 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06934265, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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