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

NCT05689307 | Completed FDA Device

• 1 other identifier: SIVA-VS2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

• Performance of the SIVA-MVP cough detection device

  Validation of a SIVA-MVP performance of detecting individual cough events in a target population over a 24-hour validation phase (first 24 hours after baseline visit). Sensitivity, specificity, and positive and negative predictive values contribute to a description of cough monitor performance.

  First 24 hours

Secondary Outcomes (6)

• Wearing comfort

  2 weeks

• Number of potential adverse events, serious adverse events, device deficiency and serious device deficiency

  2 weeks

• Comparison of objectively recorded (device) data and subjectively reported (patient) data measured with Leicester Cough Questionnaire and Cough Severity VAS

  At Baseline and at the end of 2 weeks

• Wearing time

  2 weeks

• Effective reply rate

  2 weeks

Study Arms (1)

SIVA-MVP

EXPERIMENTAL

Wearable cough detection device with a corresponding smartphone application and charging device.

Device: SIVA-MVP

Interventions

SIVA-MVP DEVICE

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.

SIVA-MVP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Siva Health AG: lead

Study Sites (1)

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, Washington, 98225, United States

Location

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 19, 2023
• Study Start: March 2, 2023
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)