Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage of participants with triggered/positive laryngeal adduction response (LAR)
研究概览
简要总结
A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.
详细描述
PRIMARY OBJECTIVES:
I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).
II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).
SECONDARY OBJECTIVES:
I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <=18 years.
- •Individuals without a laryngopharyngeal disorder (health controls) or with a laryngopharyngeal disorder. Laryngopharyngeal disorder includes but is not limited to: presbylarynx, aspiration; spasmodic dysphonia; globus pharynges; vocal fold paralysis; iatrogenic injury to the larynx; muscle tension dysphonia; neurogenic dysphagia; laryngeal sensory neuropathy; and laryngopharyngeal disorders resulting from prior radiation therapy in individuals with a history of head and neck cancer who have completed radiation therapy as primary or adjuvant cancer treatment
- •Ability and willingness to comply with study procedures.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Non-English speaking.
- •Laryngopharyngeal structures are not accessible on exam.
- •Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy.
- •Vocal fold immobility or severe hypomobility on adduction.
- •For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed).
结局指标
主要结局
Percentage of participants with triggered/positive laryngeal adduction response (LAR)
时间窗: 1 day
Elicitation of LAR is defined as a unilateral or bilateral laryngeal adduction immediately following laryngeal stimulus through frame-by-frame analysis of video recordings (visualized on laryngoscopy). An acceptable tactile stimulus is near orthogonal (less than 30 degrees deviation) to the mucosal surface and unobstructed by salivary forces. The percentage of participants with LAR will be reported
Median scores on the Penetration-Aspiration Scale (PAS)
时间窗: 1 day
The PAS is a widely-used ordinal scale metric used to describe severity of aspiration. The PAS score is multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material). The PAS is an 8-point ordinal scale, with a total score ranging from 1 representing the least and 8 representing the highest or most severe score.
次要结局
- Percentage of participants with visualized laryngopharyngeal responses(1 day)
- Median scores on the participant-reported laryngeal sensation (PRLS)(1 day)