AeviceMD for Pediatric Asthma Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-05

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma Asthma in Children Pediatric Asthma Chronic Respiratory Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AeviceMD

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

Group Type OTHER

AeviceMD

Intervention Type DEVICE

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

Interventions

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AeviceMD

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

Intervention Type DEVICE

Eligibility Criteria

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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