Validation and Evaluation of a Novel Cough Detection Device

Chronic Cough Clinical Trial

Official title: Validation and Evaluation of a Novel Cough Detection Device

Status Completed

Clinical Trial Summary

When diagnosing chronic cough (cough lasting longer than 8 weeks), the physician nowadays very often relies on the patient's narrative and description. In our research project we want to find out whether a cough detector can continuously and reliably record the cough, how the user-friendliness of the cough detector is assessed and whether this continuous recording can support the physician in his diagnosis.

Clinical Trial Description

After chronic cough diagnosis, the Principal Investigator (or his designee) will identify patients who are potentially eligible to participate in this pilot study, based on the predefined inclusion criteria.

A number of 25 participants will be recruited for this pilot study: 10 suffering from chronic cough with unclear underlying cause, 4-6 suffering from COPD, 4-6 suffering from Asthma and 4-6 suffering from interstitial lung disease.

Patients who choose to participate will be entered into the pilot study after obtaining their informed consent, when they will receive the SIVA-P3 wearable (and charging device), helped to download the SIVA-P3 smartphone application and couple the wearable component with the smartphone.

Furthermore, they will be asked to rate their current cough severity on a visual analog scale (Cough Severity VAS). Participants will receive an envelope with a second Cough Severity VAS and a return envelope to send back the SIVA-P3 wearable and charging device at the end of the study.

Participants will receive standard care and will be asked to wear the wearable component during the day, charge it on the bedside while sleeping and to otherwise go about daily life as they would do normally for a duration of seven days. In the evening of every day, they will be prompted by the SIVA-P3 smartphone application to indicate the timing of their main meals.

On day 8, the study nurse will conduct a pre-scheduled phone interview with each participant. The phone interview will include instructing the patient to fill in the final Cough Severity VAS, asking the questions of the Participant User Feedback Questionnaire, and instructing the patient to send the Cough Severity VAS form and the SIVA-P3 wearable (and charging device) back to the trial site using the return envelope. The Participant User Feedback Questionnaire will include ratings of wearing comfort, usability and likeliness to wear for extended period of time. ;

Related Conditions & MeSH terms

• Chronic Cough
• Cough

• NCT number: NCT04861155
• Study type: Interventional
• Source: Evoleen AG
• Status: Completed
• Phase: N/A
• Start date: April 22, 2021
• Completion date: October 26, 2021