Status:

COMPLETED

Validation and Evaluation of a Novel Cough Detection Device

Lead Sponsor:

Evoleen AG

Collaborating Sponsors:

University Hospital, Zürich

Conditions:

Chronic Cough

Eligibility:

All Genders

18+ years

Phase:

NA

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 whet...

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 cr...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 22 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 26 2021

Estimated Enrollment :

29 Patients enrolled

Trial Details

Trial ID

NCT04861155

Start Date

April 22 2021

End Date

October 26 2021

Last Update

November 23 2021

Active Locations (1)

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1

University Hospital Zurich

Zurich, Switzerland, 8091