AeviceMD for Pediatric Asthma Management (APAM)

Irina Dralyuk

Status: Enrolling

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

Treatments: Device: AeviceMD

Study type: Interventional

Funder types: Other

Identifiers

NCT06321471

STUDY00002858

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

AeviceMD

Other group

Description:

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

Treatment:

Device: AeviceMD