Phonation Resistance Training Exercises (PhoRTE®) Delivered In-person and Via Telehealth: A Noninferiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Voice Handicap Index-10
研究概览
简要总结
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:
- Does voice therapy (called PhoRTE®) work as well through video calls as it does face-to-face?
- 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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
CAPE-V audio sample listeners will be blinded.
入排标准
- 年龄范围
- 54 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
PhoRTE - IP
PhoRTE® voice therapy will be administered to this treatment arm in-person (IP)(traditional therapy).
干预措施: exuberant voice therapy (Behavioral)
PhoRTE - TH
Study participants who will be receiving intervention via telehealth. Intervention administered will be PhoRTE® voice therapy.
干预措施: exuberant voice therapy (Behavioral)
结局指标
主要结局
Voice Handicap Index-10
时间窗: up to 16 weeks
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).
Aging Voice Index
时间窗: up to 16 weeks
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.
Voice Problem Impact Scales
时间窗: up to 16 weeks
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).
Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
时间窗: up to 16 weeks
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).
OMNI Vocal Effort Scale
时间窗: up to 16 weeks
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.
Acoustic Assessment: Cepstral Peak Prominence
时间窗: up to 16 weeks
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).
Acoustic Assessment: voicing intensity
时间窗: up to 16 weeks
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).
Aerodynamic Measurement: phonatory airflow during speech
时间窗: up to 16 weeks
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.
Aerodynamic Measurement: subglottal pressure
时间窗: up to 16 weeks
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.
Aerodynamic Measurement: phonation threshold pressure
时间窗: up to 16 weeks
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.
Aerodynamic Measurement: number of breaths
时间窗: up to 16 weeks
mean number of breaths across a standardized reading passage (The Rainbow Passage) collected at baseline (initial evaluation) and once again after intervention (final evaluation).
duration across standardized reading passage
时间窗: up to 16 weeks
mean duration (in seconds) to complete the reading of a standard passage (The Rainbow Passage).
次要结局
未报告次要终点
研究者
Aaron Rothbart, PhD
Clinical Assistant Professor of Otolaryngology - Head and Neck Surgery (Clinician Educator)
University of Southern California