Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-25
2026-10-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PhoRTE - IP
PhoRTE® voice therapy will be administered to this treatment arm in-person (IP)(traditional therapy).
exuberant voice therapy
exuberant voice therapy validated for patients with age-related voice changes (i.e., vocal fold atrophy, presbyphonia)
PhoRTE - TH
Study participants who will be receiving intervention via telehealth. Intervention administered will be PhoRTE® voice therapy.
exuberant voice therapy
exuberant voice therapy validated for patients with age-related voice changes (i.e., vocal fold atrophy, presbyphonia)
Interventions
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exuberant voice therapy
exuberant voice therapy validated for patients with age-related voice changes (i.e., vocal fold atrophy, presbyphonia)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
54 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Responsible Party
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Aaron Rothbart, PhD
Clinical Assistant Professor of Otolaryngology - Head and Neck Surgery (Clinician Educator)
Principal Investigators
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Aaron Rothbart, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Voice Center
Arcadia, California, United States
USC Voice Center
Beverly Hills, California, United States
USC Voice Center
Glendale, California, United States
USC Voice Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Intervention approach website
Other Identifiers
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APP-24-06117
Identifier Type: -
Identifier Source: org_study_id
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