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NCT05689307
Validation Study With a Non-CE Marked Medical Device (MD)
Conditions: Chronic Cough
Sex: All
Ages: 21 Years – N/A
Phase: NA
Enrollment: 50
Sponsor: Siva Health AG
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Informed Consent as documented by signatureAdult men and women at the date of signing the Informed Consent FormPatients with a diagnosis or suspicion of refractory chronic cough or patients with a diagnosed asthmaAttending the treatment procedure as an outpatientComfortable 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 dementiaUse 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 abuseParticipation in another clinical study
Source: ClinicalTrials.gov (NCT05689307). StuddyBuddy aggregates publicly available trial information.