AeviceMD for Pediatric Asthma Management

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Aged 3 to 18 as of first recruitment

• Diagnosed with poorly controlled asthma

• Asthma control test score below

• Caregiver able operate a mobile application

• Has access high-speed wireless internet (WiFi) at home

• Able to read English

• Agreement to adhere to medical device use regimen throughout the study duration

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Irina Dralyuk, MD
Irina.Dralyuk@cshs.org
310-423-4433
Backup
Bobby Marker
Robert.Marker@cshs.org
310-423-0901
Time Frame
Start Date: 2024-11-05
Estimated Completion Date: 2026-02
Participants
Target number of participants: 20
Treatments
Other: AeviceMD
This is a single site, single arm, open label medical device (AeviceMD) pilot where only intervention groups will be recruited.
Related Therapeutic Areas
Sponsors
Collaborators: Aevice Health Pte. Ltd.
Leads: Irina Dralyuk

This content was sourced from clinicaltrials.gov

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