Validation and Evaluation of a Novel Cough Detection Device

NCT04861155 | Completed

• 1 other identifier: SIVA-PS1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (8)

• Wearing Time

  7 days

• Wearing Comfort

  7 days

• Awareness of wearing the device

  7 days

• Usability

  7 days

• Continued Wearing Likeliness

  7 days

Study Arms (1)

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.

Device: SIVA-P3

Interventions

SIVA-P3 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.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• 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).

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

Sponsors & Collaborators

• Evoleen AG: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

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 Officials

• Christian Clarenbach, PhD. Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

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: April 20, 2021
• First Posted: April 27, 2021
• Study Start: April 22, 2021
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

CH (1)