Evaluating the Therapeutic Use of a Vibratory Positive Expiratory Pressure Device (Acapella® Choice) in the Treatment of Pathological Voice - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)
研究概览
简要总结
A feasibility study to identify the immediate effect on the voices of patients with voice disorders (muscle tension dysphonia, vocal fold palsy or presbylaryngis) produced by exercising with Acapella Choice as a form of semioccluded vocal tract exercise (SOVTE).
详细描述
This feasibility study is the natural extension of the researchers' recently completed study (R&D 16/0242) which assessed how the use of an Acapella Choice (Smiths Medical) positive expiratory pressure (PEP) device as a semi-occluded vocal tract exercise (SOVTE) impacted acoustic, electroglottographic and aerodynamic measures of the voice in a group of normophonic volunteers. In that study, Acapella Choice was found to offer significantly greater oscillating intraoral pressures than techniques in current clinical practice and was found to have measurable benefits in terms of producing a louder and more economical voice. It offered the largest oscillating pressures, likened to a 'massage' of the vocal organs, giving it great therapeutic promise for patients with excess vocal tract tension.
This study seeks to evaluate the immediate effects of Acapella Choice as a voice exercise in patients with Muscle Tension Dysphonia, Presbylaryngis and Vocal Fold Palsy, and compare this to the widely-used voice rehabilitation technique of phonation into a tube held under water (henceforward referred to as "Tube"). Patients will be recruited from four weekly Voice Clinics held at the Royal National Throat Nose and Ear Hospital where their diagnosis will be confirmed. They will be invited to attend a single experimental session during which time they will exercise both with Acapella Choice and with Tube. Baseline and outcome voice measures will be taken and a short questionnaire will be completed, eliciting perceptions of the two exercises and any changes which were felt to have resulted from them.
The researchers' previous work suggests that Acapella Choice as a SOVTE may offer significant clinical benefits in terms of improved efficacy of therapy. It is suggested that it also offers patients a more convenient and user-friendly form of exercise which may well improve compliance and result in better outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand written English without the need for an interpreter,
- •No diagnosed communication impairment
- •Endoscopically confirmed primary ENT diagnosis of either:
- •muscle tension dysphonia (with no laryngeal abnormality),
- •Vocal fold palsy
- •Presbylaryngis.
排除标准
- •Previous SLT input
- •Any of the following possible contraindications for PEP therapy:
- •Inability to tolerate increased work of breathing,
- •ICP (intracranial pressure) > 20mm Hg,
- •Recent facial/oral/skull surgery or trauma,
- •Oesophageal surgery,
- •Untreated pneumothorax,
- •Known or suspected tympanic membrane rupture/other middle ear pathology,
- •Haemodynamic instability,
- •Acute sinusitis,
- •Epistaxis,
- •Active haemoptysis,
结局指标
主要结局
Change in Baseline Cepstral/Spectral Index of Dysphonia (CSID)
时间窗: Immediately after 3 minutes of exercise
A quantitative, multivariate, dysphonia summary tool that incorporates spectral (low/high spectral ratio) and cepstral measures (cepstral peak prominence), and their standard deviations, extracted from a continuous speech or sustained vowel sample utilising the software Analysis of Dysphonia in Speech and Voice (Kay Pentax, Montvale, NJ). The software calculates CSID on the scale of 0-100, whereby 0 represents no evidence of hoarse voice, and 100 represents a maximum amount of hoarseness. See: Awan SN, Roy N, Dromey C. Estimating dysphonia severity in continuous speech: Application of a multi-parameter spectralcepstral model estimating dysphonia severity in continuous speech. Clinical Linguistics and Phonetics. 2009;23(11):825-841. doi:10.3109/02699200903242988.
次要结局
- Change in Baseline Sound Pressure Level (dB)(Immediately after 3 minutes of exercise)
- Change in Baseline Mean Contact Quotient(During 3 minutes of exercise (continual) and immediately following exercise.)
- Change in Subglottic Pressure(During 3 minutes of exercise (continual))
- Transglottic Airflow(During 3 minutes of exercise (continual))
- Change in Baseline Laryngeal Resistance(Immediately after 3 minutes of exercise)
- Change in Baseline Perceptual Voice Quality(Immediately after 3 minutes of exercise)
- Change in Baseline Participant Self-ratings - Voice Quality(Immediately after 3 minutes of exercise)