Treating Laryngeal Hyperfunction With Flow Phonation
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Laryngeal Airway Resistance (Rlaw) Change Over Time
研究概览
简要总结
The purposes of the proposed study are: a) to determine whether Flow Phonation can decrease Laryngeal Resistance (Rlaw) in patients with Muscle Tension Dysphonia (MTD); and b)establish the relationship between changes in measures of Rlaw and phonatory airflow to endoscopic, perceptual, acoustic, and handicap assessment ratings. MTD can have a debilitating effect on individuals who rely on their voices the most-teachers, preachers,salespeople, singers-costing them time, money, and even their jobs. It can lead to vocal fatigue, pain, and complete loss of voice. While treatments have emerged with some promising effects, no treatments have proven to have long-term benefits to all patients. Our preliminary data demonstrate Flow Phonation training resulted in significant decreases in Laryngeal Resistance to phonatory airflow with associated improvements in voice quality and voice handicap ratings. Sample size for our pilot study was small; no control group was utilized; and outcome measures were limited. In the proposed investigation, a larger sample will be obtained, a control group of participants receiving only Vocal Hygiene Training will be used for comparison during the first 3 weeks, and a wider range of outcome measures will be included over a longer period of time (1 year).
详细描述
All participants will complete the Evaluation Protocol at baseline, after 3 weeks (PERIOD 1),after 6 weeks (PERIOD 2), and for follow-up at 3, 6, and 12 months post-treatment. During PERIOD 1 (first 3 weeks), participants in ARM 1 will receive Vocal Hygiene Training as well as Airflow Exercise Training and participants in ARM 2 (the Control Arm) will receive only Vocal Hygiene Training. Vocal hygiene training alone has been demonstrated to have minimal impact on voicing32-34. During Period 2 (second 3 weeks), participants in BOTH ARMS will receive Vocal Hygiene Training and Airflow Exercise Training (Fig 3). Thus, participants in Arm 2 will receive no Flow Phonation for initial controlled comparison then 3 weeks of Flow Phonation for dose response comparison to Arm 1 (non-control) participants.
Assessment Protocol
Each participant will receive the Complete Evaluation Protocol at Baseline, after 3 weeks(PERIOD 1), after an additional 3 weeks (PERIOD 2), as well as at 3, 6, and 12 months posttreatment. These will include:
a. Laryngostroboscopic Examination b) Perceptual Voice Analysis/CAPE-V48-49 c) Acoustic Analysis/Computerized Speech Lab(CSL, KayPENTAX Corp) d) Aerodynamic Analysis/The KayPENTAX Phonatory Aerodynamic System (PAS) Model 6600 (KayPENTAX Corp.
e) Patients' Perception of Voice Handicap/Voice Handicap Index
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rlaw greater than 1 standard deviation above or below mean
- •Voice Handicap Index of greater than 18
- •CAPE-V severity of 20 or greater
- •willing to sign informed consent
- •women must not have experienced menopause or be pregnant
排除标准
- •organic lesion of the vocal folds
- •history of neurologic disease
- •history of head and neck cancer
- •pulmonary disease
研究组 & 干预措施
12 Exercise Sessions
Patients will receive 12 treatment sessions with flow phonation exercises, as well as education on vocal hygiene.
干预措施: Vocal Hygiene Training (Behavioral)
12 Exercise Sessions
Patients will receive 12 treatment sessions with flow phonation exercises, as well as education on vocal hygiene.
干预措施: Flow Phonation Exercises (Behavioral)
6 Hygiene and 6 Exercise
Patients will receive 6 sessions of vocal hygiene training for initial comparison to patients in Arm 1. They will then receive 6 sessions of vocal exercise training and vocal hygiene training combined.
干预措施: Vocal Hygiene Training (Behavioral)
6 Hygiene and 6 Exercise
Patients will receive 6 sessions of vocal hygiene training for initial comparison to patients in Arm 1. They will then receive 6 sessions of vocal exercise training and vocal hygiene training combined.
干预措施: Flow Phonation Exercises (Behavioral)
结局指标
主要结局
Laryngeal Airway Resistance (Rlaw) Change Over Time
时间窗: 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months
Measured using the KayPENTAX Phonatory Aerodynamic System during a voice efficiency task (i.e., repeating "apapapapapapapa."
次要结局
- Voice Handicap Index (VHI)(3 weeks, 6 weeks, 12 weeks, 6 months, 12 months)
- Consensus Auditory Perceptual Evaluation - Voice(3 weeks, 6 weeks, 12 weeks, 6 months, 12 months)
- Noise-to-Harmonic Ratio(3 weeks, 6 weeks, 12 weeks, 3 months, 12 months)
研究者
Gary H. McCullough
Professor, Interim Dean of Graduate School
University of Central Arkansas