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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05112757
Other study ID # ICBE-S-000283
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 24, 2022
Est. completion date December 8, 2022

Study information

Verified date December 2022
Source Philips Electronics Nederland B.V. acting through Philips CTO organization
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis


Description:

The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.


Recruitment information / eligibility

Status Terminated
Enrollment 77
Est. completion date December 8, 2022
Est. primary completion date December 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health - 18 years or older, with sufficient English language skills - Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11<) - Able to download and handle an app on a smartphone - Willing and able to give informed consent Exclusion criteria: - Diagnosed with OSA and/or AFib - Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.) - Pregnancy/breast feeding

Study Design


Intervention

Other:
Smartphone application use
Use of a smartphone application

Locations

Country Name City State
United States Sandford Health Sioux Falls South Dakota

Sponsors (2)

Lead Sponsor Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effective conversion Number of patients that visited the Primary Care Physician 6 months after consent
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