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临床试验/NCT02407301
NCT02407301已完成不适用

Voluntary Cough Airflow Dynamics and True Vocal Fold Kinematics in Persons With Reduced True Vocal Fold Mobility

University of Florida2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Peak expiratory flow rate (PEFR)

研究概览

简要总结

This project is a first attempt to assess cough airflow dynamics and true vocal fold (TVF) adduction and abduction angles during voluntary cough to examine the effects of changes in glottal closure due to reduced mobility of one true vocal fold. The hypothesis of this study is that the incomplete glottal closure due to reduced vocal fold mobility will result in changes in true vocal fold adductory and abductory angles during cough and will result in changes to voluntary cough airflow parameters. This study results will contribute to the existing knowledge of the laryngeal contribution to cough airflow dynamics.

详细描述

The study investigators will consecutively recruit 30 adults diagnosed with vocal fold insufficiency due to reduced mobility of one true vocal fold.

A questionnaire will be used to collect participants' information. Demographic information such as age, gender, race/ethnicity, height, weight, and a major complaint (dysphonia and/or dysphagia) and medical history information determining the eligibility for participation will be collected from the participant. Participant's medical and surgical history specifically related to the diagnosis and the etiology of reduced vocal fold mobility will be obtained from the participant's medical record.

Videolaryngoscopy will be performed as part of standard clinical care. Vocal fold image and cough airflow will be recorded simultaneously during voluntary cough production with the flexible endoscope in nasopharynx. A second part of the study will include spirometry and expiratory muscle strength assessments. Video images of the vocal fold movement during vowel phonation and cough production will be recorded and stored on a CD for later analysis. The cough airflow recordings will be displayed, stored, and analyzed using LabChart software for Windows.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 40 and 75 years.
  • Glottal insufficiency secondary to reduced TVF mobility confirmed with the endoscopic evaluation performed by an otolaryngologist.
  • The ability to provide informed consent.
  • No history of chronic obstructive pulmonary disease, lung cancer, and/or lung transplant.
  • No history of neurodegenerative disease such as Parkinson's disease, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), or progressive supranuclear palsy (PSP), Alzheimer's disease, or dementia.

排除标准

  • Chest infection within one month prior to the study participation.
  • History of the adverse reaction associated with laryngoscopy.

结局指标

主要结局

Peak expiratory flow rate (PEFR)

时间窗: baseline

Maximum flow rate in expiratory phase, expressed in liters per second (L/s)

True vocal fold maximum abduction angles in inspiratory phase

时间窗: baseline

The TVF maximum abduction angles during cough inspiratory phase of cough will be expressed in degrees.

True vocal fold maximum abduction angles in expiratory phase

时间窗: baseline

True vocal fold maximum abduction angles in expiratory phase of cough will be expressed in degrees.

True vocal fold maximum adduction angles in compression phase

时间窗: baseline

True vocal fold maximum adduction angles in compression phase of cough will be expressed in degrees.

Peak expiratory flow rise time (PEFRT)

时间窗: baseline

Time to reach peak expiratory flow rate expressed in seconds

Cough volume acceleration (CVA)

时间窗: baseline

A ratio of peak expiratory flow rate and peak expiratory flow rise time expressed in L/s/s

Expiratory phase duration

时间窗: baseline

Duration of expiratory phase of cough expressed in seconds

次要结局

  • Peak expiratory flow(baseline)
  • Maximum expiratory pressure(baseline)
  • Degree of glottal closure(baseline)
  • Forced vital capacity (FVC)(baseline)
  • Forced expired volume within 1 second (FEV1)(baseline)
  • The ratio FEV1/FVC(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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