Prevalence of Nocturnal Cough in Asthma and its Potential as a Marker for Asthma Control (MAC) in Combination with Sleep Quality: Protocol of a Smartphone-based, Multi-Centre, Longitudinal Observational Study with Two Stages

Introduction: Nocturnal cough is a burdensome asthma symptom. However, knowledge about the prevalence of nocturnal cough in asthma is limited. Furthermore, prior research has shown that nocturnal cough and impaired sleep quality are associated with asthma control, but the association between these two symptoms remains unclear. This study further investigates the potential of these symptoms as markers for asthma control and the accuracy of automated, smartphone-based passive monitoring for nocturnal cough detection and sleep quality assessment.
Methods and analysis: The study is a multi-centre, longitudinal observational study with two stages. Sensor and questionnaire data of 94 asthmatics will be recorded for 28 nights by means of a smartphone. On the first and the last study day, a participant’s asthma will be clinically assessed, including spirometry and fractionated exhaled nitric oxide (FeNO) levels. Asthma control will be assessed by the Asthma Control Test (ACT) and sleep quality by means of the Pittsburgh Sleep Quality Index (PSQI). In addition, nocturnal coughs from smartphone microphone recordings will be labelled and counted by human annotators. Relatively unrestrictive eligibility criteria for study participation are set to support external validity of study results. Analysis of the first stage is concerned with the prevalence and trends of nocturnal cough and the accuracies of smartphone-based automated detection of nocturnal cough and sleep quality. In the second stage, patient-reported asthma control will be predicted in a mixed effects regression model with nocturnal cough frequencies and sleep quality of past nights as the main predictors.
Ethics and dissemination: The study was reviewed and approved by the ethics commission responsible for research involving humans in eastern Switzerland (BASEC ID: 2017-01872). It is registered at clinicaltrials.gov (NCT03635710). All study data will be anonymized upon study termination. Results will be published in medical and technical peer-reviewed journals.