AeviceMD for Pediatric Asthma Management (APAM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma; Asthma in Children; Chronic Respiratory Disease; Pediatric Asthma
• Intervention / Treatment: Device: AeviceMD

Detailed Description

Participants are asked to take part in this research study because they have been diagnosed with poorly controlled 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 a participant's own ability to understand, monitor, and manage their conditions when at home. The investigators know that for pediatric patients, 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 vital signs and detect wheezing when worn at home. The continued use of this device (especially during night sleep) gives insight to the course of symptoms, while also providing early warning should a participant's condition worsen. The device can also be used as a digital stethoscope, meaning physicians can examine participants via teleconference and obtain useful data for clinical decision making.

Study participants include: 20 pediatric patients (between 3 to 18 years of age) who have been diagnosed with poorly controlled asthma while presenting at Cedars-Sinai Medical Center Guerin Children's. Participants will be enrolled to use the AeviceMD device during night sleeps.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AeviceMD; This is a single site, single arm, open label medical device (AeviceMD) pilot where only intervention groups will be recruited.	Device: AeviceMD; AeviceMD is a remote patient monitoring system consisting of a wearable stethoscope, silicone patches, a docking station, and a mobile application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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-item questionnaire resulting in a sum score ranging from 0 (best asthma control) to 19 (worst asthma control). A decrease in the sum score indicates an improvement in asthma control.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Irina Dralyuk
• Collaborators: Aevice Health Pte. Ltd.
• Investigators: Principal Investigator: Irina Dralyuk, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Wearable Medical Device
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: STUDY00002858

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No