Measuring the Prevalence of Nocturnal Cough in Asthmatics by Means of Smartphone-enabled Acoustic Recording and Evaluating the Potential of Nocturnal Cough Rate as a Prognostic Marker for Asthma Control: An Observational Two-Stage Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Coughs per night assessed by smartphone audio recording
研究概览
简要总结
The purpose of the study is to explore the value which cough rate might provide for asthma self-management. In this study, the focus will be specifically on nocturnal cough rate. The plan is to use a longitudinal study design, in order to investigate to which extent trends in the nocturnal cough rates might have meaningful implications for future asthma control and asthma exacerbations of patients. The incidence of nocturnal cough in asthmatics will be described and visualized over the course of one month in the first stage of the study. Additionally, the aim will be to identify and model trends in nocturnal cough rates.
Measuring cough is very time-consuming. Currently, there are no cough frequency monitors available, which measure cough rates in a fully automated and unobtrusive way. Consequently, manual labeling of cough based on video or sound recordings is still considered to be the gold standard for measuring cough rates by medical guidelines. Recently, a machine learning algorithm was successfully designed to automatically detect cough in a proof of concept study. This machine learning algorithm will be further developed in order to provide robust results in the field. The focus of this study will be the cough during the night time due to the limited interfering noise, which greatly facilitates manual labeling and enables a more reliable detection rate of the machine learning algorithm.
Apart from developing a machine learning algorithm for cough detection, data will be gathered for the assessment of patient's sleep quality based on data obtained from smartphone's sensors.
详细描述
Asthma, a chronic respiratory disease, belongs to the most prevalent chronic conditions. In Switzerland, 7-15% of all children and 6-7% of all adults suffer from it. Common symptoms are breathlessness, coughing and wheezing. The symptoms often get worse at night and often cause awakenings. Cough is a particularly important symptom in asthma because it predicts asthma severity, indicates a worse prognosis and is perceived to be a troublesome symptom. Additionally, asthma is the leading cause for chronic cough, responsible for 24-29% of cases.
However, little is known about the utility of cough tracking for self-monitoring purposes in asthmatics. A first cross-sectional study has indicated that the cough rate during both day and night might be a valid marker for asthma control, rendering it a potentially useful parameter for self-monitoring. Unfortunately, due to considerable variance of cough rates within each category of asthma control (i.e. uncontrolled, partially controlled and controlled asthma), the statistically significant relationship between cough rate and asthma control might not be clinically meaningful. Additionally, due to the cross-sectional design of existing studies, it remains unclear whether the cough rate might have any prognostic value for predicting future asthma control.
Therefore, the purpose of this study is to explore the value which cough rate might provide for asthma self-management in more detail. In This study, the focus will be put specifically on nocturnal cough rate due to the technical reasons. In general, the plan of this study is as follows: With a longitudinal study design, it is possible to investigate to which extent trends in the nocturnal cough rates might have meaningful implications for future asthma control and asthma exacerbations of patients. However, in order to analyze the predictive value of trends in nocturnal cough rate, the symptom has to persist over multiple nights. There is no research available on the prevalence of nocturnal cough in asthmatics over multiple nights. Therefore, the incidence of nocturnal cough in asthmatics will be described and visualized over the course of one month in the first stage of our study. Additionally, the aim will be to identify and model trends in nocturnal cough rates.
Measuring cough is very time-consuming. Currently, there are no cough frequency monitors available, which measure cough rates in a fully automated and unobtrusive way. Consequently, manual labeling of cough based on video or sound recordings is still considered to be the gold standard for measuring cough rates by medical guidelines. Nevertheless, a machine learning algorithm has been successfully designed to automatically detect cough in a proof of concept study. Despite using only very limited data for algorithm development (80 coughs from 5 healthy subjects), the accuracy reached 83%. However, the data were gathered in a laboratory setting, which limits the generalizability of the results and thus applicability in practice. Therefore, the aim is to develop a machine learning algorithm which is also capable to provide robust results in the field. This study will focus on cough during the night time due to the limited interfering noise, which greatly facilitates manual labeling and enables a more reliable detection rate of the machine learning algorithm. It is important to point out that the analysis of nocturnal cough prevalence described above will not be based on cough detected by an algorithm, but on the manually labeled coughs in the audio track recorded during the night by a study smartphone, which will be provided to subjects for the course of the study.
Apart from developing a machine learning algorithm for cough detection, data will be gathered for an algorithm assessing patient's sleep quality. For this purpose, sleep quality will be predicted based on data obtained from the smartphone's sensors.
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
- 否
入选标准
- •all patients with physician-diagnosed asthma (obtained through self-reports)
- •minimum age 18 years
- •proficient in using a smartphone (e.g. for the daily smartphone-based self-
排除标准
- •patients with mental diseases resulting in cognitive impairments such as depression, dementia, and Alzheimer's disease
- •patients for whom it would not be feasible to obtain reliable nighttime measurements (i.e. patients with severe insomnia or shift workers) or for whom we cannot ensure the correct allocation of nocturnal coughs to the patient in the rating process (i.e. patients who usually share the bed with a person from the same sex).
结局指标
主要结局
Coughs per night assessed by smartphone audio recording
时间窗: 28 days
Number of coughs per night measured by means of smartphone audio recording
次要结局
- Detection rates of two machine learning algorithms(28 days)
- Sleep quality (Pittsburgh sleep quality index)(28 days)
研究者
Frank Rassouli
Attending Physician, Lung Center
Cantonal Hospital of St. Gallen
