Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of cough skill training
研究概览
简要总结
This preliminary study will examine the feasibility of a cough skill training treatment approach to rehabilitate voluntary cough function in people with head and neck cancer. Cough skill training focuses on practicing cough as a compensatory strategy for when food or liquid enters the airway. Primary outcomes will be feasibility and immediate treatment effects. The investigators hypothesize that the treatment will be feasible and will result in improvements to voluntary cough peak expiratory flow rate.
详细描述
Participants will complete an initial in-person baseline evaluation of voluntary cough function, followed by five weekly telehealth treatment sessions for five weeks with home practice, before completing a post-treatment in-person evaluation. During each treatment session with study personnel and during home practice, they will complete 25 repetitions (5 sets of 5) of voluntary coughs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of head and neck cancer at least 6 months post-diagnosis
- •Completed treatment for head and neck cancer, including surgery, radiation, or chemotherapy
- •Medically stable and able to follow commands and produce a voluntary cough
- •English speaking
排除标准
- •Unable to provide informed consent assessed by a Montreal Cognitive Assessment (MoCA) score of <20
- •Unable to follow study instructions
- •Unable to produce a voluntary cough
- •History of neurologic disease
- •Recent laryngeal surgery or vocal fold injury
- •Active respiratory infection or febrile illness within the past 14 days
- •Chronic, severe, or unstable respiratory disease
- •Asthma or bronchitis
- •Smoking within the past five years
- •Uncontrolled hypertension
- •Recent myocardial infarction, unstable angina, stroke, or hospitalization for heart failure within the past 6 months
- •Significant uncontrolled arrhythmia
研究组 & 干预措施
Cough skill training
Participants will use a handheld cough device to produce voluntary coughs during 5 one hour treatment sessions.
干预措施: Handheld cough device (Device)
结局指标
主要结局
Feasibility of cough skill training
时间窗: 6 weeks
Feasibility of cough skill training will be defined as the percentage of trials completing during treatment sessions.
次要结局
- Change in voluntary cough peak expiratory flow rate(baseline, 6 weeks)
- Acceptability assessed by the System Usability Scale(6 weeks)
- Satisfaction assessed by the Beck Satisfaction Scale(6 weeks)