跳至主要内容
临床试验/NCT05029986
NCT05029986已完成不适用

Self-Regulated Airflow Management in Daily Communicative Activities to Prevent Dyspnea During Speech in Older Speakers

University of Delaware1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change in reported dyspnea

研究概览

简要总结

Due to various comorbidities affecting the respiratory system, older speakers are at risk of experiencing breathing discomfort (dyspnea) during high-demand vocal activities such as singing, loud speaking, and speaking while exercising. Dyspnea during speech can promote avoidance of certain situations involving voice production, thus leading to vocal deconditioning and decreased quality of life. The goal of this pilot study is to test the feasibility and acceptability of a 4-week remote group intervention targeting phonatory dyspnea, and to gather preliminary efficacy data.

Participants will receive an intervention including a 2-week socialization phase (control condition) and a 4-week speech breathing intervention phase (experimental condition). Both phases will be delivered remotely and in a group setting (10 participants per group).

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •sign the informed consent form
  • •report dyspnea in at least one of the items of the University of Cincinnati Dyspnea Questionnaire referring to speech
  • •be available during the dates of the scheduled group interventions
  • •be aged 50 years or older

排除标准

  • •do not have access to a computer and internet connection
  • •present with a known voice pathology (other than age-related vocal fold atrophy) and/or are receiving speech therapy at the time of the study
  • •have a known neurodegenerative disease affecting speech/voice
  • •are a current smoker
  • •are receiving pulmonary rehabilitation at the time of the study or are starting a new medication regimen for a respiratory disease at the time of study onset;
  • •have a hearing loss that is not adequately managed, as judged by the Principal Investigator (PI)
  • •have professional vocal training [amateur choir singers will not be excluded]
  • •cannot provide informed consent or easily follow instructions
  • •have any other condition that precludes them from participating in the behavioral interventions, as judged by the PI.

研究组 & 干预措施

All participants

Experimental

This is a single-arm trial. All participants will receive (1) a control condition (socialization phase, 2 weeks) and (2) an intervention condition (speech breathing intervention, 4 weeks). Group sessions will take place once a week, and participants will be instructed to practice their exercises every day at home during the study duration.

干预措施: Socialization phase (Behavioral)

All participants

Experimental

This is a single-arm trial. All participants will receive (1) a control condition (socialization phase, 2 weeks) and (2) an intervention condition (speech breathing intervention, 4 weeks). Group sessions will take place once a week, and participants will be instructed to practice their exercises every day at home during the study duration.

干预措施: Speech breathing intervention (Behavioral)

结局指标

主要结局

Change in reported dyspnea

时间窗: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.

Participant self-ratings of dyspnea on the University of Cincinnati Dyspnea Questionnaire. This questionnaire contains 30 items scored on a Likert scale ranging from 1 (not at all short of breath) to 5 (always short of breath or cannot do). A higher scores indicates greater shortness of breath and therefore greater handicap.

Change in reported voice handicap

时间窗: Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.

Participant self-ratings of voice handicap on the Voice Handicap Index-10. The Voice Handicap Index-10 is an ordinal scale that measures the degree of handicap a person experiences because of their voice disorder. Each item is scored on a Likert scale ranging from 0 to 4. The minimum score is 0 and the maximal score 40. A higher score indicates a greater perceived voice handicap.

次要结局

  • Change in reported self-efficacy(Assessed at baseline, after the 2-week control condition, and after the 4-week experimental condition.)
  • Acceptability of the intervention(Assessed after the 4-week experimental condition, at the end of the study period.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maude Desjardins

Post-doctoral researcher

University of Delaware

研究点 (1)

Loading locations...

相似试验