Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05689307
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-24
First Post:
2023-01-06
Brief Title:
Validation Study With a Non-CE Marked Medical Device MD
Sponsor:
Siva Health AG
Organization:
Siva Health AG
Study Overview
Official Title:
Validation Study With a Non-CE Marked Medical Device MD
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None