Clinical trial NCT06934265: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrophy of Vocal Cord
Presbyphonia
Dysphonia
Glottic Insufficiency
Voice Change
Voice Disorder
Adults
Aging
Speech Therapy
Voice Alteration
Keywords: Vocal fold atrophy
voice therapy
presbyphonia
aging voice
voice rehabilitation
speech pathology
Intervention
voice
aging
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 54
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each group will get the same intervention; however, delivery method will differ (in-person vs telehealth-delivered)
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Voice Handicap Index-10
timeFrame: up to 16 weeks
measure: Aging Voice Index
timeFrame: up to 16 weeks
measure: Voice Problem Impact Scales
timeFrame: up to 16 weeks
measure: Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
timeFrame: up to 16 weeks
measure: OMNI Vocal Effort Scale
timeFrame: up to 16 weeks
measure: Acoustic Assessment: voicing intensity
timeFrame: up to 16 weeks
measure: Acoustic Assessment: Cepstral Peak Prominence
timeFrame: up to 16 weeks
measure: Aerodynamic Measurement: phonatory airflow during speech
timeFrame: up to 16 weeks
measure: Aerodynamic Measurement: subglottal pressure
timeFrame: up to 16 weeks
measure: Aerodynamic Measurement: phonation threshold pressure
timeFrame: up to 16 weeks
measure: Aerodynamic Measurement: number of breaths
timeFrame: up to 16 weeks
measure: duration across standardized reading passage
timeFrame: up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: USC Voice Center
state: California
city: Beverly Hills
country: United States
facility: USC Voice Center
state: California
city: Glendale
country: United States
facility: USC Voice Center
state: California
city: Los Angeles
country: United States
facility: USC Voice Center
state: California
Study officials:
affiliation: University of Southern California
name: Aaron Rothbart, PhD
role: PRINCIPAL_INVESTIGATOR
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