NCT05689307

Validation Study With a Non-CE Marked Medical Device (MD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Siva Health AG · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This interventional study aims to validate the cough detection device by automatically and continuously measuring the cough frequency with SIVA-MVP among chronic cough patients and in a real-world environment.

Detailed description

After chronic cough diagnosis, the Principal Investigator (or his designee) will identify potentially eligible patients to participate in this study based on the predefined inclusion criteria. The study will recruit patients with a cough that has lasted for at least 12 months and persistent for the previous 8 weeks with a diagnosis or suspicion of refractory chronic cough, or patients with a diagnosed asthma. A total of 50 patients will be enrolled in the study. Patients who decide to participate will be entered into the study after obtaining their informed consent. They will receive the SIVA-MVP wearable and the associated accessories. They will be asked to rate their current cough severity on a visual analog scale (Cough Severity VAS) and fill in a Leicester Cough Questionnaire (LCQ) to assess the impact of cough on their quality of life. Participants will receive a second Cough Severity VAS and LCQ to fill at the end of the study and a return envelope. Participants will receive standard care and be asked to wear SIVA-MVP on their chest during the day and charge it on the bedside during sleep for 14 days. Every evening, they will be prompted by the SIVA-MVP smartphone application to indicate the timing of their main meals. On day 15, 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 and LCQ, asking the questions of the Participant User Feedback Questionnaire, and instructing the patient to send the questionnaire forms and the SIVA-MVP wearable and the accessories 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 an extended period of time.

Conditions

• Chronic Cough

Interventions

Type	Name	Description
DEVICE	SIVA-MVP	Participants receive a small, wearable data recorder, wear it during the day and charge it on the nightstand during sleep for 14x24 hours. The encrypted, recorded segments are uploaded to a server. The server provides a secure environment where the segments are decrypted after receiving the required keys from the patient's SIVA smartphone application. The decrypted segments are then classified as cough by a machine learning algorithm. Participants respond to questions on a smartphone once a day for additional context data. The audio data from the first 24 hours after the patient started wearing the device are used for the validation of the performance of the cough detection algorithm.

Timeline

• Start date: 2023-03-02
• Primary completion: 2024-11-22
• Completion: 2024-11-22
• First posted: 2023-01-19
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study