Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321471
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-14
Brief Title:
AeviceMD for Pediatric Asthma Management
Sponsor:
Irina Dralyuk
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
AeviceMD for Pediatric Asthma Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APAM
Brief Summary:
A wearable remote patient monitor AeviceMD is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study Patients prescribed with AeviceMD should be able to gain better control over their disease during home management Physicians should be able to optimize treatment for these patients using objective data collected from and of these patients outside of the clinic The AeviceMD should also be used as a remote auscultation device for teleconsultations
Detailed Description:
You are asked to take part in this research study because you have been diagnosed with asthma As a chronic respiratory disease management of the disease relies not only on healthcare professionals delivering care at various clinical touch points but also depends heavily on your own ability to understand monitor and manage your conditions when you are at home We know that for you like for many other children self-monitoring is often difficult This clinical pilot investigates the use of a wearable medical device that can conduct continuous monitoring of your vital signs and detect wheezing when worn at home The continued use of this device especially during your night sleep gives insight to the course of symptoms while also providing early warning should your condition worsen The device can also be used as a digital stethoscope using which physicians can examine you over a teleconference and obtain useful data for clinical decision making
The study will include up to 20 pediatric subjects between age 3 to 18 with poorly controlled asthma presenting at Cedars-Sinai Medical Center Guerin Childrens will be enrolled for using AeviceMD device during night sleeps
The study will include up to 20 pediatric subjects between age 3 to 18 with poorly controlled asthma presenting at Cedars-Sinai Medical Center Guerin Childrens will be enrolled for using AeviceMD device during night sleeps
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None