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

Siva Health

Status

Completed

Conditions

Chronic Cough

Treatments

Device: SIVA-MVP

Study type

Interventional

Funder types

Industry

Identifiers

NCT05689307

SIVA-VS2

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed Consent as documented by signature
Adult men and women at the date of signing the Informed Consent Form
Patients with a diagnosis or suspicion of refractory chronic cough or patients with a diagnosed asthma
Attending the treatment procedure as an outpatient
Comfortable with using a smartphone and willing to use an external iPhone daily for the duration of the study.
Adequate communication in US English (all study documentation and SIVA-MVP will be set to English language only).

Exclusion criteria

Unable to make the decision to participate in a clinical study (e.g., seriously ill or unconscious subject, or subject with a mental or intellectual disability)
Inability to follow the procedures of the study, e.g., due to physical or intellectual impairment precluding informed consent or protocol adherence, psychological disorders (excluding depression) or dementia
Use of any other medical device equipment (e.g., portable oxygen concentrator, artificial cardiac pacemaker, implantable cardioverter-defibrillator)
Pregnancy: Female participants in child-bearing age without a negative pregnancy test (urine test). Female participants who are neither surgically sterilized / hysterectomized nor post-menopausal for longer than 2 years are considered to be of childbearing potential.
Known or suspected non-compliance, drug or alcohol abuse
Participation in another clinical study