AeviceMD for Pediatric Asthma

(APAM Trial)

Overseen By Bobby Marker

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Irina Dralyuk

Disqualifiers: Allergy to silicone, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable device, AeviceMD, designed to help children manage asthma better at home. The device monitors breathing and sends data to doctors, enabling them to adjust treatments based on real-life information. It also facilitates remote check-ups with the doctor. Children aged 3 to 18 with poorly controlled asthma may be suitable candidates, particularly if they struggle to manage symptoms and can use a smartphone app. As an unphased trial, this study provides a unique opportunity for children to benefit from innovative technology that could enhance asthma management at home.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current asthma treatments while using the AeviceMD device, but please confirm with the trial coordinators.

What prior data suggests that the AeviceMD device is safe for pediatric asthma patients?

Research has shown that the FDA has approved the AeviceMD device for use in children, indicating a positive safety profile. FDA approval signifies that the device's safety has been reviewed based on available data. Although specific safety details for AeviceMD in this study aren't provided, its approval for use with children suggests it is likely safe.

The AeviceMD is a wearable device that monitors asthma in kids. Being non-invasive, it likely carries a low risk of side effects. Generally, wearable monitors are considered safe because they don't involve medication or surgery.

Overall, AeviceMD seems to be a safe choice for monitoring asthma in children, based on its FDA approval and non-invasive design. ^{1 2 3 4 5}

Why are researchers excited about this trial?

AeviceMD is unique because it offers a novel approach to managing pediatric asthma through a wearable medical device that continuously monitors respiratory health. Unlike standard treatments like inhalers or oral medications, which primarily focus on alleviating symptoms, AeviceMD provides real-time data to help detect early signs of asthma exacerbations. This proactive monitoring allows for timely interventions, potentially reducing the frequency and severity of asthma attacks. Researchers are excited about this treatment because it empowers both patients and caregivers with valuable insights into asthma management, making it a game-changer in personalized healthcare.

What evidence suggests that the AeviceMD device is effective for monitoring pediatric asthma?

Research has shown that the AeviceMD device could help manage asthma in children. One study found that this wearable stethoscope detected wheezing accurately, identifying it 85.3% of the time and ruling it out 80.8% of the time. This means it can accurately spot asthma symptoms in most children. Participants in this trial will use the AeviceMD device, which provides doctors with clear data from children at home. This information could lead to better asthma control and improve the quality of life for children with asthma. ^{1 6 7 8 9}

Who Is on the Research Team?

Irina Dralyuk, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for children with asthma. Participants should be currently managing their asthma and looking to improve control over the disease at home. They must be willing to use AeviceMD, a wearable monitor, as part of their treatment plan.

Inclusion Criteria

Asthma control test score below

Caregiver able to operate a mobile application

My asthma is not well-managed.

Exclusion Criteria

I have been diagnosed with sleep apnea.

Known allergy to silicone, gold, or zinc

I have skin issues on my chest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the AeviceMD device for continuous monitoring of vital signs and wheezing detection during night sleep

12 weeks

Baseline and final in-person visits, teleconsultations

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AeviceMD

Trial Overview The study tests AeviceMD, a wearable device designed to monitor respiratory health in kids with asthma. It aims to help patients manage their condition better at home and provide doctors with data for optimizing treatment.

How Is the Trial Designed?

Group I: AeviceMD Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Irina Dralyuk

Lead Sponsor

Trials

1

Recruited

20+

AEvice Health Pte Ltd

Collaborator

Trials

2

Recruited

60+

Aevice Health Pte. Ltd.

Collaborator

Trials

3

Recruited

220+

Published Research Related to This Trial

A review of 326 spontaneous adverse drug reaction reports for asthma medications in children revealed that approximately 85% of these reports were serious, including six fatal cases, highlighting significant safety concerns.

The most commonly reported adverse reactions were psychiatric disorders (13%), respiratory issues (10%), and skin disorders (9%), with budesonide, salbutamol, and fluticasone being the medications with the highest number of reported ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. Aagaard, L., Hansen, EH.[2021]

A comprehensive analysis of 372,345 spontaneous reports from 2011 to 2017 identified 385 different safety signals related to asthma medications in children, with a notable focus on psychiatric events, highlighting the importance of monitoring these drugs in the pediatric population.

The study uncovered new safety signals, such as herpes viral infections linked to omalizumab and hypertrichosis associated with budesonide, emphasizing that age stratification is crucial for detecting unique risks in children that may not be evident in the broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Baan, EJ., de Smet, VA., Hoeve, CE., et al.[2021]

A systematic review of 46 studies on pediatric asthma medications revealed that inhaled corticosteroids (ICS) are associated with 174 adverse drug events (ADE), including potential issues like adrenal and growth suppression.

Serious adverse drug events were rare, occurring in 0.9-6% of cases, and there were no confirmed deaths in pediatric patients, although methodological concerns were noted regarding the identification and assessment of ADE in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of adverse drug events associated with administration of common asthma medications in children. Leung, JS., Johnson, DW., Sperou, AJ., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06321471

NCT06321471 | AeviceMD for Pediatric Asthma Management It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. atsjournals.org atsjournals.org/doi/pdf/10.1164/ajrccm.2025.211.Abstracts.A2296?download=true

Evaluating a Wearable Device for Wheeze Detection in the ... This study assessed the AeviceMD, a cloud-connected smart wearable stethoscope as a solution for wheeze monitoring in children presenting with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06377345

Study Details | NCT06377345 | Remote Patient Monitoring ... The aim of the study is to evaluate the clinical outcomes, self-efficacy, quality of life, utility, and cost-effectiveness of the Aevice device for asthma self- ...

4. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A2296

Evaluating a Wearable Device for Wheeze Detection in the ... Results: The AeviceMD demonstrated strong performance in detecting wheeze in enrolled patients, with a sensitivity of 85.3% and a specificity of 80.8%, ...

5. east.vc east.vc/from-portfolios-3/aevice-health-worlds-smallest-wearable-stethoscope-asthma-treatment

Aevice Health: Wearable stethoscope transforms asthma ... Aevice Health introduces AeviceMD, the world's smallest wearable stethoscope designed to support asthma treatment. Read the full story!

6. trialx.com trialx.com/clinical-trials/listings/297034/aevicemd-for-pediatric-asthma-management/

AeviceMD for Pediatric Asthma Management Patients prescribed with AeviceMD should be able to gain better control over their disease during home management.

7. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/STUDY00002858

AeviceMD for Pediatric Asthma Management This study focuses on children who have been diagnosed with asthma. The goal of the study is to evaluate the use of a wearable medical device.

8. clinconnect.io clinconnect.io/trials/NCT06321471

AeviceMD for Pediatric Asthma Management (NCT06321471) A wearable remote patient monitor (AeviceMD) is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study.

9. aevice.com aevice.com/sg/press/aevice-health-and-nuhs-launches-study

Aevice Health and NUHS Launches Study To Detect Lung ... Aevice Health Secures US FDA Clearance for Pediatric Use of AeviceMD, a Remote Respiratory Monitoring Platform Enabled by Smart Wearable Stethoscope · Aevice ...