PhoRTE® Therapy Efficacy: In-Person Versus Telehealth

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Voice Handicap Index-10 [Time frame: up to 16 weeks]
• Aging Voice Index [Time frame: up to 16 weeks]
• Voice Problem Impact Scales [Time frame: up to 16 weeks]
• Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) [Time frame: up to 16 weeks]
• OMNI Vocal Effort Scale [Time frame: up to 16 weeks]
• Acoustic Assessment: voicing intensity [Time frame: up to 16 weeks]
• Acoustic Assessment: Cepstral Peak Prominence [Time frame: up to 16 weeks]
• Aerodynamic Measurement: phonatory airflow during speech [Time frame: up to 16 weeks]
• Aerodynamic Measurement: subglottal pressure [Time frame: up to 16 weeks]
• Aerodynamic Measurement: phonation threshold pressure [Time frame: up to 16 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• USC Voice Center — Arcadia
• USC Voice Center — Beverly Hills
• USC Voice Center — Glendale
• USC Voice Center — Los Angeles

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 27145396

Identifiers

NCT: NCT06934265 · APP-24-06117

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗