Clinical trial NCT06321471: AeviceMD for Pediatric Asthma Management
Official title: AeviceMD for Pediatric Asthma Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Asthma in Children
Pediatric Asthma
Chronic Respiratory Disease
Keywords: Wearable Medical Device
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Aevice Health Pte. Ltd.
First posted: 2024-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 Months
Secondary outcomes:
measure: To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations.
timeFrame: 3 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Irina Dralyuk, MD
role: PRINCIPAL_INVESTIGATOR
References: