The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Severity of spasmodic dysphonia symptoms
研究概览
简要总结
This study will compare the effects of vocal rest versus continuous vocalization for one hour immediately following botulinum toxin injections for adductor spasmodic dysphonia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with adductor spasmodic dysphonia (ADSD) by an experienced neurologist and otolaryngologist. ADSD patients who have been stabilized on their treatment dose for at least 2 treatment cycles.
排除标准
- •Diagnosed with another neurological disorder that is combined with ADSD (i.e. Parkinson's disease and ADSD). Previous history of an additional vocal pathology (i.e. vocal polps, vocal nodules, unilateral vocal fold paralysis, etc.)
研究组 & 干预措施
Vocal activity
The vocal activity arm will require the participant to remain in the clinic and read aloud continuously for a period of one hour after a botulinum toxin injection
干预措施: Vocal rest versus vocalization (Behavioral)
Vocal rest
The vocal rest arm will require the participant to remain in the clinic and remain on complete vocal rest for a period of one hour after a botulinum toxin injection
干预措施: Vocal rest versus vocalization (Behavioral)
结局指标
主要结局
Severity of spasmodic dysphonia symptoms
时间窗: Six weeks post-treatment
Acoustic measures and perceptual ratings of vocal spasm severity
Patient-reported outcome measures of symptoms and communication
时间窗: six weeks post-treatment
Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy
次要结局
未报告次要终点