Impact of External Pharyngeal Exerciser on Pharyngeal Phase of Swallowing

Medical College of Wisconsin1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2014年9月16日最近更新: 2026年1月14日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Medical College of Wisconsin
入组人数: 60
试验地点: 1
主要终点: baseline UES pressure

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study of healthy young and elderly individuals is intended to assess the effects of pharyngeal exerciser on pharyngeal pressure phenomenon during swallowing. Our specific aim is to test if the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing.

详细描述

All the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study.
The participant's neck's physical dimensions and the device's physical dimensions will be measured and recorded. A physical examination including carotid artery auscultation will be performed.
After the application of local lidocaine, the high-resolution manometry (HRM) catheter will be inserted through the more patent nares and positioned such that it covers the entire pharynx from the nasopharynx to the proximal esophagus. In this position, manometry recording of the entire pharynx will be possible.
The pharyngeal exerciser will be placed around the neck overlying the larynx. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of the neck.
Patients will be sitting in an upright position and acclimatized for 10 minutes before proceeding.
Each subject will perform the following swallows:
Dry swallows x 5 times.

5 ml and 10 ml- of water swallows at room temperature x 5 times each.

5 ml and 10 ml- mashed potato swallowed at room temperature x 5 times each.

8. The sequence of the swallow types will be randomized. The swallow will be performed under device pressure of zero, 20, 30, 40 and 60 mm Hg in a randomized fashion. Each swallow type will be repeated 5 times with 30-second intervals in between.

9. The externally applied pressure will be measured by means of the pressure gauge included in the device

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
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: 是

入选标准

•Healthy volunteers must be at least 18 years of age or older.

排除标准

•Subjects with cervical spine disorders.
•Subjects with neurological disorders like dementia, cerebrovascular diseases other than Parkinson's Disease
•Subjects with carotid artery bruit or carotid vascular disorders.
•Subjects suffering from muscle diseases like muscular dystrophies, myopathies.
•Subjects with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders.
•Subjects with any current esophageal symptoms like heartburn, dysphagia, chest pain or regurgitation.
•Subjects cannot have previous head or neck surgery or radiation.
•Subjects unable to tolerate nasal intubation.
•Subjects with significant bleeding disorders for whom nasal intubation has been deemed contraindicated.
•Subjects with a known upper airway or esophageal obstruction preventing the passage of the manometry probe.
•Subjects with autonomic dysfunction.
•Subjects having a history of allergy to lidocaine and barium.
•Subjects who are pregnant or lactating.
•Subjects who have advanced medical disorders (e.g.: chronic obstructive pulmonary disease (COPD), congestive heart failure, cirrhosis, cancer, chronic renal failure, etc.).
•Subjects who are medically unstable.

研究组 & 干预措施

Pharyngeal exerciser group

Experimental

Test that application of the pharyngeal exerciser increases the workload of muscles involved in pharyngeal phase of swallowing as evidenced manometrically by changes in

Pharyngeal peak pressures Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile duration Pharyngeal (velopharynx, oropharynx and hypopharynx) contractile integral Hypopharyngeal intrabolus pressure and duration UES nadir pressure UES relaxation time Baseline UES pressure

干预措施: Pharyngeal exerciser (Device)