EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy

赞助:

合作者:

信息的提供 (责任方):

Jacqueline Gartner-Schmidt，University of Pittsburgh

追踪信息

首次提交日期 ^ICMJE

September 20, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

July 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Mean Change From Baseline VHI-10 Score at 5 Weeks[ Time Frame: At each study visit through study completion; Time 0 (therapy visit1), after week 1 (therapy visit 2), after week 2 (therapy visit 3), after week 3 (therapy visit 4), after week 5 (follow up visit) ]

The Voice Handicap Index-10 (VHI-10) is a validated assessment instrument that quantifies patient perceptions of his or her own voice handicap. A lower score on the VHI-10 indicates perception of a lesser voice handicap than a high score. Scores range from 0 to 40.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Mean Change From Baseline AVI Score at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
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.
Mean Change From Baseline Acoustic Measurements at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Cepstral Spectral Index of Dysphonia (CSID), a multifactorial estimate of dysphonia severity that correlates with the visual analog scale for overall voice severity used in the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V), Cepstral Peak Prominence and its standard deviation, Cepstral Peak Prominence Fundamental Frequency (CPP F0) and its standard deviation, and mean vocal intensity in dB SPL.
Mean Change From Baseline CSID Measurements at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Cepstral Spectral Index of Dysphonia (CSID), a multifactorial estimate of dysphonia severity that correlates with the visual analog scale for overall voice severity used in the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) while reading functional phrases.
Mean Change From Baseline Cepstral Peak Prominence at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Acoustic measurement: Cepstral Peak Prominence and its standard deviation while reading functional phrases.
Mean Change From Baseline Cepstral Peak Prominence Fundamental Frequency at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Acoustic measurement: CPP F0 while reading functional phrases.
Mean Change From Baseline Vocal Intensity at 5 weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Acoustic measurement: mean vocal intensity in dB SPL while reading functional phrases.
Mean Change From Baseline Phonatory Airflow in Speech at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Mean phonatory airflow in speech in reading of a standard passage (The Rainbow Passage).
Mean Change From Baseline Number of Breaths at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Aerodynamic measurement: mean number of breaths in reading of a standard passage (The Rainbow Passage).
Mean Change From Baseline Vocal Intensity at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Aerodynamic measurement: mean vocal intensity in reading of a standard passage (The Rainbow Passage).
Mean Change From Baseline Duration of Standard Reading Passage at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Aerodynamic measurement; mean duration to complete the reading of a standard passage (The Rainbow Passage).
Mean Change In Overall Voice Severity at 5 Weeks[ Time Frame: At initial therapy visit and final follow up-visit, after week 5 ]
Overall voice severity determined by Consensus Auditory Perceptual Evaluation - Voice (CAPE-V) score provided by blinded raters. The visual analog scale for overall voice severity used. Minimum score = 0, Maximum score = 100. Higher values indicate worse voice.

描述性信息

简略标题 ^ICMJE

EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy

正式标题 ^ICMJE

EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy

简要概况

The larynx and vocal folds undergo many age-related changes in their physiology and structure that can lead to undesirable effects on the voice, with changes in the respiratory system compounding these deficits. These changes, also called presbyphonia, can have serious detrimental effects on the lives of elderly individuals. There are few studies that have evaluated the use of voice therapy treatment options for these patients. The primary aim of this study is to test whether the addition of expiratory muscle strength training (EMST) to a current, validated voice therapy protocol aimed at treating presbyphonia, (phonation resistance training, PhoRTE) can improve outcomes of therapy.

详细说明

The purpose of this study is to test whether the addition of EMST to PhoRTE Voice Therapy is at least as effective as PhoRTE alone for improving acoustic, aerodynamic, and patient-reported outcomes in patients affected by age-related vocal fold atrophy. Voice therapy is often the first-line treatment for patients experiencing presbyphonia. Despite being the most common treatment for presbyphonia, scant literature exists on the efficacy of voice therapy for these patients. The current proposal aims to add to this growing body of literature. In general, studies of existing voice therapy programs for presbyphonia have demonstrated success in achieving improvement in aerodynamic (increased subglottal pressure), acoustic (increased shimmer, jitter, and decreased noise-to-harmonics ratio), and patient-centered outcomes (reduction in Voice Handicap Index scores, decreased phonatory effort). Ziegler et al. conducted a study comparing a standard voice therapy, Vocal Function Exercises (VFE) and Phonation Resistance Training Exercises (PhoRTE) and found that both therapies improved outcomes of voice-related quality of life, but only PhoRTE gave a statistically significant reduction in perceived phonatory effort. A specific therapy designed to address age-related changes to respiratory system is expiratory muscle strength training (EMST). EMST devices are loaded with a resistive spring which opens when a desired level of expiratory pressure is reached and maintained. Maintenance of consistent subglottal pressure is the foundation for phonation. EMST device training improves active expiratory muscle forces required for high-pressure activities such as long utterances or loud speech in vocally healthy individuals. When used in conjunction with traditional voice therapy, EMST use has also shown to increase maximum phonation time, maximum expiratory pressure, dynamic range, subglottal pressure, and perception of voice handicap in professional voice users over traditional voice therapy alone. The theoretical underpinnings for treatment of vocal fold atrophy with EMST are clear, as it addresses many of the common goals of treatment in patients with presbyphonia, but it has not yet been tested as a possible adjunctive treatment for patients undergoing voice therapy.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:Speech Language Pathologists (SLPs) will not know which group the participants have been randomized to.
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: EMST
Training of the respiratory system muscles using the EMST device.
Behavioral: PhoRTE
Completing of PhoRTE voice therapy.

研究工具

Active Comparator: PhoRTE
This group will undergo standard PhoRTE therapy.
Experimental: PhoRTE + EMST
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 2019

预计主要完成日期

July 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Age 65 or older - Diagnosis of presbyphonia (vocal fold atrophy) made by a fellowship-trained laryngologist and a voice specialized speech language pathologist - Willingness to be randomized to one of two treatments Exclusion Criteria: - Any concomitant laryngeal diagnoses or diseases known to affect voice function, including: amyloidosis, arytenoid dislocation, laryngeal cancer, cricoarytenoid fixation, vocal fold cyst(s), vocal nodules, vocal fold polyp(s), dysplasia, vocal fold fibrous mass(es), glottal web, vocal fold immobility, laryngeal stenosis, laryngocele, leukoplakia, Parkinson's disease, Reinke's edema, respiratory recurrent pneumonia, sarcoidosis, spasmodic dysphonia - Any chronic lower airway disease such as chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, emphysema, cystic fibrosis - History of acute stroke - Untreated hypertension - Untreated gastroesophageal reflux disease (GERD)

性别

参与研究的性别:

All

年龄

最小年龄：65 Years ，最大年龄：95 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: Yes

IPD 共享声明

计划分享 IPD:

责任方

Jacqueline Gartner-Schmidt，University of Pittsburgh

研究赞助商 ^ICMJE

Jacqueline Gartner-Schmidt

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Jacqueline Gartner-Schmidt University of Pittsburgh Voice Center

PRS 账户

University of Pittsburgh

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名