PhoRTE® Therapy Efficacy: In-Person Versus Telehealth

NCT06934265 | Not Yet Recruiting

• 1 other identifier: APP-24-06117
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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 make treatment more accessible and affordable for seniors. The two primary hypotheses are:

• 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.

Conditions

Glottic Insufficiency; Voice Change; Speech Therapy; Voice Alteration; Atrophy of Vocal Cord; Presbyphonia; Dysphonia; Voice Disorder; Adults; Aging

Keywords

Vocal fold atrophy; voice therapy; presbyphonia; aging voice; voice rehabilitation; speech pathology; Intervention; voice; aging

Outcome Measures

Primary Outcomes (12)

• 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).

  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.

  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).

  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).

  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.

  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).

  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).

  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.

  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.

  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.

  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).

  up to 16 weeks

• duration across standardized reading passage

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

  up to 16 weeks

Study Arms (2)

PhoRTE - IP

ACTIVE COMPARATOR

PhoRTE® voice therapy will be administered to this treatment arm in-person (IP)(traditional therapy).

Behavioral: exuberant voice therapy

PhoRTE - TH

EXPERIMENTAL

Study participants who will be receiving intervention via telehealth. Intervention administered will be PhoRTE® voice therapy.

Behavioral: exuberant voice therapy

Interventions

exuberant voice therapy BEHAVIORAL

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®)

PhoRTE - IP; PhoRTE - TH

Eligibility Criteria

• Age: 54 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (4)

USC Voice Center

Arcadia, California, 91007, United States

Location

USC Voice Center

Beverly Hills, California, 90211, United States

Location

USC Voice Center

Glendale, California, 91204, United States

Location

USC Voice Center

Los Angeles, California, 90033, United States

Location

Related Publications (13)

• 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.

  PMID: 30315575 BACKGROUND

• 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.

  PMID: 34654233 BACKGROUND

• 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.

  PMID: 32680804 BACKGROUND

• 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.

  PMID: 35446741 BACKGROUND

• 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.

  PMID: 24375313 BACKGROUND

• 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.

  PMID: 37809138 BACKGROUND

• 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.

  PMID: 28147896 BACKGROUND

• 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.

  PMID: 27145396 BACKGROUND

• 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.

  PMID: 33780433 BACKGROUND

• 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.

  PMID: 33741235 BACKGROUND

• 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.

  PMID: 18930908 BACKGROUND

• 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.

  PMID: 34933795 BACKGROUND

• 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.

  PMID: 15475780 BACKGROUND

Related Links

• Intervention approach website

MeSH Terms

Conditions

Dysphonia; Voice Disorders; Communication Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aaron Rothbart, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: CAPE-V audio sample listeners will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Otolaryngology - Head and Neck Surgery (Clinician Educator)

Model Details: Each group will get the same intervention; however, delivery method will differ (in-person vs telehealth-delivered)

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 18, 2025
• Study Start: January 25, 2026
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): October 25, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)