Chronic CoughNCT04861155
Validation and Evaluation of a Novel Cough Detection Device
A study testing SIVA-P3 in people with Chronic Cough, run by Evoleen AG at 1 site in Switzerland.
Trial summary
When diagnosing chronic cough (cough lasting longer than 8 weeks), the physician nowadays very often relies on the patient's narrative and description. In our research project we want to find out whether a cough detector can continuously and reliably record the cough, how the user-friendliness of the cough detector is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cough
- What is being tested?
- SIVA-P3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Apr 2021to 26 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Men and women, aged 18 and over at date of signing the Informed Consent Form
- Patients diagnosed with a chronic cough of unknown origin or COPD or Asthma or with interstitial lung disease.
- Attending the treatment procedure as an outpatient
- Using a smartphone (minimal version: iOS 13 / Android 10) on a daily basis and willing to install SIVA-P3 smartphone application
- Adequate communication in German or Swiss-German (all study documentation and SIVA-P3 will be set to German 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 as being 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.
About this study
When diagnosing chronic cough (cough lasting longer than 8 weeks), the physician nowadays very often relies on the patient's narrative and description. In our research project we want to find out whether a cough detector can continuously and reliably record the cough, how the user-friendliness of the cough detector is assessed and whether this continuous recording can support the physician in his diagnosis.
Read the detailed description
After chronic cough diagnosis, the Principal Investigator (or his designee) will identify patients who are potentially eligible to participate in this pilot study, based on the predefined inclusion criteria.
A number of 25 participants will be recruited for this pilot study: 10 suffering from chronic cough with unclear underlying cause, 4-6 suffering from COPD, 4-6 suffering from Asthma and 4-6 suffering from interstitial lung disease.
Patients who choose to participate will be entered into the pilot study after obtaining their informed consent, when they will receive the SIVA-P3 wearable (and charging device), helped to download the SIVA-P3 smartphone application and couple the wearable component with the smartphone.
Furthermore, they will be asked to rate their current cough severity on a visual analog scale (Cough Severity VAS). Participants will receive an envelope with a second Cough Severity VAS and a return envelope to send back the SIVA-P3 wearable and charging device at the end of the study.
Participants will receive standard care and will be asked to wear the wearable component during the day, charge it on the bedside while sleeping and to otherwise go about daily life as they would do normally for a duration of seven days. In the evening of every day, they will be prompted by the SIVA-P3 smartphone application to indicate the timing of their main meals.
On day 8, 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, asking the questions of the Participant User Feedback Questionnaire, and instructing the patient to send the Cough Severity VAS form and the SIVA-P3 wearable (and charging device) 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 extended period of time.
- Conditions
- Chronic Cough
- Being tested
- SIVA-P3
- 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-P3Device
Digital cough recording: Participants receive a small, wearable data recorder, wear it during waking hours and keep it on the nightstand during sleep for 7x24 hours. The data is sent to a smartphone application, where a cough detection algorithm converts it into time-stamped cough events. Participants respond to questions on their smartphone once a day for additional context data. The cough events and context data are sent to a secure online database for further evaluation. For the first 24 hours, segments of audio data are sent to be able to validate the performance of the cough detection algorithm. Afterwards, only cough events and context data are sent from the participant's smartphone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The experimental intervention uses the SIVA-P3 system, the prototype of a digital solution aiming to support the diagnostic process in cases of chronic cough. The SIVA-P3 system primarily consists of a wearable audio and movement recorder and a smartphone app for the patient. Receives: Device: SIVA-P3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation
The primary outcomes are sensitivity, specificity and related metrics (positive and negative predictive values, rates of false positive and false negative detections per hour) for cough frequency measurement of SIVA-P3 in the target patient 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: 24 hours
Secondary outcomes (8)
Wearing Time
The wearable device continuously records movement data. This movement data is used to determine if the wearable device is being worn.
Measured: 7 days
Wearing Comfort
Wearing Comfort will be determined through quantitative analysis of closed and open questions in the Participant User Feedback Questionnaire.
Measured: 7 days
Awareness of wearing the device
Patients will be questioned via the smartphone application how many times they have approximately noticed during the day that they have been wearing the device.
Measured: 7 days
Usability
Usability from the patient's perspective will be determined through quantitative analysis of closed questions in the Participant User Feedback Questionnaire.
Measured: 7 days
Continued Wearing Likeliness
Continued Wearing Likeliness will be determined through quantitative analysis of closed and open questions in the Participant User Feedback Questionnaire.
Measured: 7 days
Correlation of patient-reported cough severity
Cough Severity Correlation will be determined by correlating daily cough counts determined by the SIVA-P3 algorithm with the patient's self-reported Cough Severity VAS.
Measured: 7 days
Variations of time course of coughing between different days within individual patients
To compare the variations of time course of coughing, the hourly profiles of each day will be interpreted as discrete distribution functions. A range of statistical features associated with properties of distributions will be calculated for all profiles and compared both within individual patients and across the whole population. These features will include mean, median, variance, skewness, kurtosis and additional descriptive statistics for multimodal distributions.
Measured: 7 days
Diagnostic prediction models
To evaluate the predictive performance of a mathematical model, different models will be explored. The outcome is the performance of the best predictive model identified.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start22 Apr 2021
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evoleen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Christian Clarenbach, PhD. Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861155
- Sponsor's protocol ID
- SIVA-PS1
- Status last verified
- Nov 2021
- First submitted
- 20 Apr 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Evaluation of a Novel Cough Detection Device
- ClinicalTrials.gov ID
- NCT04861155
- Acronym / sponsor ID
- SIVA-PS1
- Conditions
- Chronic Cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Evoleen AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Zürich
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 27 Apr 2021 (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.
When diagnosing chronic cough (cough lasting longer than 8 weeks), the physician nowadays very often relies on the patient's narrative and description. In our research project we want to find out whether a cough detector can continuously and reliably record the cough, how the user-friendliness of the cough detector is assessed and whether this continuous recording can support the physician in his diagnosis.
Detailed description
After chronic cough diagnosis, the Principal Investigator (or his designee) will identify patients who are potentially eligible to participate in this pilot study, based on the predefined inclusion criteria.
A number of 25 participants will be recruited for this pilot study: 10 suffering from chronic cough with unclear underlying cause, 4-6 suffering from COPD, 4-6 suffering from Asthma and 4-6 suffering from interstitial lung disease.
Patients who choose to participate will be entered into the pilot study after obtaining their informed consent, when they will receive the SIVA-P3 wearable (and charging device), helped to download the SIVA-P3 smartphone application and couple the wearable component with the smartphone.
Furthermore, they will be asked to rate their current cough severity on a visual analog scale (Cough Severity VAS). Participants will receive an envelope with a second Cough Severity VAS and a return envelope to send back the SIVA-P3 wearable and charging device at the end of the study.
Participants will receive standard care and will be asked to wear the wearable component during the day, charge it on the bedside while sleeping and to otherwise go about daily life as they would do normally for a duration of seven days. In the evening of every day, they will be prompted by the SIVA-P3 smartphone application to indicate the timing of their main meals.
On day 8, 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, asking the questions of the Participant User Feedback Questionnaire, and instructing the patient to send the Cough Severity VAS form and the SIVA-P3 wearable (and charging device) 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 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 |
|---|---|---|
| Intervention Arm | Experimental | Device: SIVA-P3The experimental intervention uses the SIVA-P3 system, the prototype of a digital solution aiming to support the diagnostic process in cases of chronic cough. The SIVA-P3 system primarily consists of a wearable audio and movement recorder and a smartphone app for the patient. |
Who may qualify
- Ages
- 18 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
- Men and women, aged 18 and over at date of signing the Informed Consent Form
- Patients diagnosed with a chronic cough of unknown origin or COPD or Asthma or with interstitial lung disease.
- Attending the treatment procedure as an outpatient
- Using a smartphone (minimal version: iOS 13 / Android 10) on a daily basis and willing to install SIVA-P3 smartphone application
Key exclusion criteria (5 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 as being of childbearing potential.Known or suspected non-compliance, drug or alcohol abuse
- Participation in another clinical study
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-P3Digital cough recording: Participants receive a small, wearable data recorder, wear it during waking hours and keep it on the nightstand during sleep for 7x24 hours. The data is sent to a smartphone application, where a cough detection algorithm converts it into time-stamped cough events. Participants respond to questions on their smartphone once a day for additional context data. The cough events and context data are sent to a secure online database for further evaluation. For the first 24 hours, segments of audio data are sent to be able to validate the performance of the cough detection algorithm. Afterwards, only cough events and context data are sent from the participant's smartphone. | Device | Intervention Arm |
Primary outcome
Validation
Time frame: 24 hours
The primary outcomes are sensitivity, specificity and related metrics (positive and negative predictive values, rates of false positive and false negative detections per hour) for cough frequency measurement of SIVA-P3 in the target patient 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.
8 secondary outcomes
Wearing Time
Time frame: 7 days
Wearing Comfort
Time frame: 7 days
Awareness of wearing the device
Time frame: 7 days
Usability
Time frame: 7 days
Continued Wearing Likeliness
Time frame: 7 days
Correlation of patient-reported cough severity
Time frame: 7 days
Variations of time course of coughing between different days within individual patients
Time frame: 7 days
Diagnostic prediction models
Time frame: 7 days
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 23 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Cough
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RecruitingPhase 2
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RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
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RecruitingPhase 3
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets
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RecruitingPhase 3
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets
Idiopathic Pulmonary Fibrosis
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.
Christian Clarenbach, PhD. Dr. med. principal investigator
University of Zurich
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-P3 in people with Chronic Cough, run by Evoleen AG at 1 site in Switzerland.
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 5 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 23 Nov 2021. 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 Switzerland. 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?
Validation (time frame: 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 23 Nov 2021.