PhoRTE® Therapy Efficacy: In-Person Versus Telehealth

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age54+
SponsorUniversity of Southern California

About this 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:

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • exuberant voice therapy

    Behavioral

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: PhoRTE - IPActive comparator 1 intervention
Group B: PhoRTE - THExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame
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.

Time frame
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).

Time frame
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).

Time frame
up to 16 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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