Validation and Evaluation of a Novel Cough Detection Device

NCT ID: NCT04861155

Last Updated: 2021-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2021-10-26

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.

Conditions

Chronic Cough

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

SIVA-P3

Intervention Type: DEVICE

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.

Interventions

SIVA-P3

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

Evoleen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Clarenbach, PhD. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

SIVA-PS1

Identifier Type: -

Identifier Source: org_study_id