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OpenTrials
Completed

NCT Number: NCT03884582

Observational Study Using the CoVa Monitoring System 3

Asthma is a complex and chronic inflammatory disorder which is associated with reversible airway obstruction and bronchial hyperresponsiveness. It is one of the most prevalent chronic diseases in children and prevalence further increases worldwide. Typical symptoms of asthma are breathlessness, cough, wheezing and chest tightness. These symptoms are particularly prevalent at night-time. Understanding and tracking these symptoms can lead to better management of asthma.

Auscultation using a stethoscope is standard clinical practice, however there is currently no available solution to detect respiratory sounds throughout the day and night.

The aim of this study is to investigate the feasibility of detecting respiratory sounds in healthy children with the CoVa patch.

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Key information

Conditions

Healthy

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

toSense,Inc.

San Diego, California, 92121, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is between the ages of 4 - 17 years old at the time of consent
  • Participant and/or family member/carer willing to give written consent
  • Participant and/or family member/carer who can read and comprehend english

Exclusion criteria

  • Subject believed to be unsuitable for inclusion by the Principle Investigator
  • Subject is pregnant at time of consent
  • Subject is currently enrolled in another medical study

Treatment and study plan

Cova Monitoring System 3

Device

Healthy Volunteers

Primary outcomes

  1. Ability to detect simulated respiratory sounds including coughing and wheezing or identify subjects which have asthma related respiratory issues

    Time frame: 2 Weeks

    Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor.

Secondary outcomes

  1. Ability to detect simulated respiratory sounds including wheeze and cough during movement such a simulated situation of moving in bed.

    Time frame: 2 Weeks

    Subjects will be asked to simulate coughing and wheezing sounds. This data will be analyzed by using a phonocardiogram (microphone) sensor while the subject is moving in the bed.

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

Observational Study to Detect Cough and Wheeze Sounds Using the CoVa Monitoring System 3

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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