AeviceMD for Pediatric Asthma Management

Asthma Clinical Trial

— APAM  

Official title:

AeviceMD for Pediatric Asthma Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06321471
• Other study ID #: STUDY00002858
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Cedars-Sinai Medical Center
• Contact: Irina Dralyuk, MD
• Phone: 310-423-4433
• Email: Irina.Dralyuk[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Children's will be enrolled for using AeviceMD device during night sleeps.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Known allergy to silicone, gold, or zinc
• Abnormal skin conditions on chest
• Sleep apnea diagnosis

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Chronic Respiratory Disease
• Pediatric Asthma
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Device:
• AeviceMD
AeviceMD is a remote patient monitoring system consisting of a wearable stethoscope, silicone patches, a docking station, and a mobile application.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Irina Dralyuk	AEvice Health Pte Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effectiveness of implementing home monitoring technology for asthma patients in delivering care to patients and in extension determine, if Aevice Medical Device can improve home management of Asthma for pediatrics patients.	The study primary objectives are met if enrolled patients achieve better manage of their asthma shown by a reduction in admission rate, improvement in patient satisfaction, and quality of life. For this purpose, the Pediatric Asthma Control and Communication Instrument (PACCI) system will be utilized. This is a 12-point questionnaire resulting in a sum score. A decrease in the sum score indicates an improvement in asthma control.	3 Months
Secondary	To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations.	The study's secondary objectives are met if a remote physician was able to conduct auscultation of a patient's lungs and discern between normal and abnormal breath using AeviceMD during teleconsultations. For this purpose the PI will test the sound quality of the AeviceMD in direct comparison to a traditional stethoscope used at baseline and final in-person visits, as well as at the tele visit.	3 Months