Feasability Assessment of wearable sensors for continuous ambulatory vital signs monitoring

Completed

Conditions: Dit betreft een validatie studie van continue metingen van vitale functies, welke niet gerelateerd is aan een enkele aandoening of orgaansysteem
Not applicable

Registration Number: NL-OMON48983

Lead Sponsor: Divisie Vitale Functies

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Study 1
10 volunteers of both sexes (*18 years of age) are eligible for enrolment, with
the following criteria:
* 5 volunteers need to be at age 65 or above
* 3 volunteers need to have a BMI >30 kg/m2, Study 2
10 volunteers ( *18 years of age) are eligible for enrolment, with the
following criteria:
* At least one hospitalization requiring monitoring in the past two years
(*former patients*)
* Currently healthy or in a stable phase of chronic illness
* 3 volunteers need to have a BMI >30 kg/m2
* 3 volunteers need to live alone (without informal carer)

Exclusion Criteria

* Known allergy/skin irritation to the adhesives used in the sensor patches.
* Implanted active medical devices, such as a cardioverter defibrillator or a
pacemaker
* Current pregnancy
* Inability to give informed consent

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Study 1<br /><br>Primary outcome is the accuracy of the vital sign parameters that each<br /><br>prototype solution measures as compared with the reference standard.<br /><br><br /><br>Study 2<br /><br>The primary outcome measure of study 2 is the usability of each of the<br /><br>prototype solutions, as measured with the system usability scale (SUS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measure of study 2 is the technical feasibility of<br /><br>ambulatory monitoring at home, which will be evaluated with the following<br /><br>metrics:<br /><br><br /><br>* Success rate of data transmission to external server or gateway device,<br /><br>calculated as percentage: [(actual data points captured / intended data points)]<br /><br>o Duration of interrupted monitoring episodes (e.g., data gaps of 15 minutes, 1<br /><br>hour, 8 hours or more)<br /><br>o Frequency of interrupted monitoring episodes (e.g., data gaps)<br /><br>o The level of accessibility of the measured data</p><br>