Chronic CoughNCT05689307
Validation Study With a Non-CE Marked Medical Device (MD)
A study testing SIVA-MVP in people with Chronic Cough, run by Siva Health AG at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Cough
- What is being tested?
- SIVA-MVP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2023to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, 98225
About this study
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.
Read the 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
- Being tested
- SIVA-MVP
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIVA-MVPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SIVA-MVP | Experimental | Wearable cough detection device with a corresponding smartphone application and charging device. Receives: Device: SIVA-MVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 24 hours
Secondary outcomes (6)
Wearing comfort
Wearing Comfort will be determined through quantitative analysis of questions in the Participant User Feedback Questionnaire measured with 5-level Likert Scale (Disagree, Somewhat disagree, Neither agree nor disagree, Somewhat agree, Agree).
Measured: 2 weeks
Number of potential adverse events, serious adverse events, device deficiency and serious device deficiency
Device safety measured as the number of potential adverse events, serious adverse events, device deficiency and serious device deficiency.
Measured: 2 weeks
Comparison of objectively recorded (device) data and subjectively reported (patient) data measured with Leicester Cough Questionnaire and Cough Severity VAS
Correlation of patient reported outcomes measured with Leicester Cough Questionnaire and Cough Severity Visual Analog Scale (VAS) with recorded cough frequency during 14x24h.
Measured: At Baseline and at the end of 2 weeks
Wearing time
Effective wearing times per day as recorded by the device.
Measured: 2 weeks
Effective reply rate
Effective reply rate of patients to questions for context information asked to them via the smartphone application
Measured: 2 weeks
Cough frequency patterns
Degree of similarity between cough patterns of different days within one patient and between patients.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start2 Mar 2023
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siva Health AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689307
- Sponsor's protocol ID
- SIVA-VS2
- Status last verified
- May 2025
- First submitted
- 6 Jan 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study With a Non-CE Marked Medical Device (MD)
- ClinicalTrials.gov ID
- NCT05689307
- Acronym / sponsor ID
- SIVA-VS2
- Conditions
- Chronic Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Siva Health AGIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIVA-MVP | Experimental | Device: SIVA-MVPWearable cough detection device with a corresponding smartphone application and charging device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIVA-MVPParticipants 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. | Device | SIVA-MVP |
Primary outcome
Performance of the SIVA-MVP cough detection device
Time frame: First 24 hours
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.
6 secondary outcomes
Wearing comfort
Time frame: 2 weeks
Number of potential adverse events, serious adverse events, device deficiency and serious device deficiency
Time frame: 2 weeks
Comparison of objectively recorded (device) data and subjectively reported (patient) data measured with Leicester Cough Questionnaire and Cough Severity VAS
Time frame: At Baseline and at the end of 2 weeks
Wearing time
Time frame: 2 weeks
Effective reply rate
Time frame: 2 weeks
Cough frequency patterns
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Cough
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIVA-MVP in people with Chronic Cough, run by Siva Health AG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the SIVA-MVP cough detection device (time frame: First 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.