Clinical trial NCT04861155: Validation and Evaluation of a Novel Cough Detection Device
Official title: Validation and Evaluation of a Novel Cough Detection Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Cough
Lead sponsor: Evoleen AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Zürich
First posted: 2021-04-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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).

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 as being of childbearing potential.Known or suspected non-compliance, drug or alcohol abuse
* Participation in another clinical study

Primary outcomes:
measure: Validation
timeFrame: 24 hours
Secondary outcomes:
measure: Wearing Time
timeFrame: 7 days
measure: Wearing Comfort
timeFrame: 7 days
measure: Awareness of wearing the device
timeFrame: 7 days
measure: Usability
timeFrame: 7 days
measure: Continued Wearing Likeliness
timeFrame: 7 days
measure: Correlation of patient-reported cough severity
timeFrame: 7 days
measure: Variations of time course of coughing between different days within individual patients
timeFrame: 7 days
measure: Diagnostic prediction models
timeFrame: 7 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Christian Clarenbach, PhD. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: