跳至主要内容
临床试验/NCT05783401
NCT05783401招募中不适用

Digital Voice Analysis as a Measure of Frailty and Distress. A Feasibility Study (DIVAN)

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Change of duration of the breaks between the words

研究概览

简要总结

This study evaluates if it is possible to identify quantitative parameters from audio signals to describe the changes in patient's state in relation to frailty and distress.

详细描述

Frailty is a common clinical syndrome especially in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality. The early detection of frailty is of importance in many patient populations to predict treatment outcomes, identify patient needs and coordinate efficient and meaningful care. An electronic assessment of the degree of distress in patients, who are unable to report, would be important to be able to routinely and objectively identify suffering in these patients. Digital voice analysis (DVA) gathers speech samples from individuals via different kinds of recording devices (smartphone, tablet, etc.) and examines a large variety of specific acoustic parameters such as for example frequency and voice quality features. This study is to analyse the potential to evaluate distress and frailty through digital voice analysis. On the contrary to the existing studies, it is intended to record audio and clinical evaluation data from the same subject multiple times during several weeks to be able to analyse temporal changes. This will allow to not only perform inter-subject but as well intra-subject comparisons of changes in audio features with changes of the patient's wellbeing over time. To make the patient speak as freely and relaxed as possible, the patient will describe different images. Different features will be extracted from the audios and potential candidates for a larger patient study will be identified, if data quantity permits using machine learning algorithms. Therefore this study evaluates if it is feasible to gather digital voice samples for voice analyses from cancer patients alongside conventional assessments for frailty (G8 questionnaire and distress (Distress Thermometer) to conduct first, preliminary analyses for identification of potential correlates between voice features and frailty or distress and between changes over time.

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

入选标准

  • Active cancer or haemato-oncological malignancy
  • Adults (≥ 18 years)
  • Ability to understand, speak and read German language fluently
  • Ability to provide written consent
  • Sufficient or corrected vision to see the images
  • Sufficient auditory comprehension for participation in the study based on the therapist's clinical opinion
  • Ability to concentrate for 20-30 minutes based on the investigator's clinical opinion
  • Signed informed consent to the study

排除标准

  • Aphonia, dysphonia or other obvious voice alterations of patient's voice
  • Life-expectancy shorter ≤ 14 days as judged by a physician or nurse via "surprise question"
  • Breathlessness whilst speaking
  • Cognitive impairment as judged by physician or Mini-Cog in the G8 screening tool
  • Severe physical, emotional or existential suffering because of which the enrollment and participation in the study would result in patient burden, as judged by the treating physicians and their multiprofessional team members

结局指标

主要结局

Change of duration of the breaks between the words

时间窗: during a 16-week period for each patient

Change of duration of the breaks between the words extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of shimmer (variation in peak-to-peak amplitude)

时间窗: during a 16-week period for each patient

Change of shimmer (variation in peak-to-peak amplitude) extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of verbal fluency

时间窗: during a 16-week period for each patient

Change of verbal fluency extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of skewness

时间窗: during a 16-week period for each patient

Change of skewness extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of kurtosis

时间窗: during a 16-week period for each patient

Change of kurtosis extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of first few formants (F1, F2)

时间窗: during a 16-week period for each patient

Change of first few formants (F1, F2) extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of voice strength (volume) of the vowel

时间窗: during a 16-week period for each patient

Change of voice strength (volume) of the vowel extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of duration of length of the answer

时间窗: during a 16-week period for each patient

Change of duration of length of the answer extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of word duration of individual words

时间窗: during a 16-week period for each patient

Change of word duration of individual words extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of mean fundamental frequency extracted from the patient's audio data

时间窗: during a 16-week period for each patient

Change of mean fundamental frequency extracted from the patient's audio data to estimate the changes in distress and frailty.

Change of jitter (variation in F0 from cycle to cycle)

时间窗: during a 16-week period for each patient

Change of jitter (variation in F0 from cycle to cycle) extracted from the patient's audio data to estimate the changes in distress and frailty.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Digital Voice Analysis as a Measure of Frailty and... | 临床试验