AeviceMD for Pediatric Asthma Management

NCT06321471 | Active Not Recruiting FDA Device

• 1 other identifier: STUDY00002858
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Asthma in Children; Pediatric Asthma; Chronic Respiratory Disease

Keywords

Wearable Medical Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations.

  3 Months

Study Arms (1)

AeviceMD

OTHER

This is a single site, single arm, open label medical device (AeviceMD) pilot where only intervention groups will be recruited.

Device: AeviceMD

Interventions

AeviceMD DEVICE

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

AeviceMD

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Irina Dralyuk: lead
• Aevice Health Pte. Ltd.: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Irina Dralyuk, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)