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Observational Study Using the CoVa Monitoring System 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884582
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
toSense, Inc.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Healthy Device: Cova Monitoring System 3

Study Design
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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study to Detect Cough and Wheeze Sounds Using the CoVa Monitoring System 3
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Groups and Cohorts
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Group/Cohort Intervention/treatment
HealthyVolunteers Device: Cova Monitoring System 3
Healthy Volunteers


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884582


Locations
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United States, California
toSense,Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
toSense, Inc.
More Information
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Responsible Party: toSense, Inc.
ClinicalTrials.gov Identifier: NCT03884582    
Other Study ID Numbers: RMD-IRB-0001
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by toSense, Inc.:
Healthy volunteers