Wearable device for managing asthma in children
AeviceMD for Pediatric Asthma Management
This study is testing a wearable device that helps kids with asthma monitor their breathing at home to see if it can improve their health and help doctors provide better care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06321471 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the use of a wearable medical device, AeviceMD, to monitor the respiratory health of pediatric patients with poorly controlled asthma. Participants, aged 3 to 18, will wear the device at home, particularly during sleep, to continuously track vital signs and detect wheezing. The data collected will help both patients and physicians manage asthma more effectively, allowing for timely interventions and teleconsultations. The study aims to empower young patients in self-monitoring their condition while providing healthcare professionals with valuable insights.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 3 to 18 with a diagnosis of poorly controlled asthma.
Not a fit: Patients with known allergies to silicone, gold, or zinc, or those diagnosed with sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve asthma management and control for pediatric patients.
How similar studies have performed: Other studies utilizing wearable devices for chronic disease management have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Irina Dralyuk, MD — Cedars-Sinai Medical Center
- Study coordinator: Irina Dralyuk, MD
- Email: Irina.Dralyuk@cshs.org
- Phone: 310-423-4433
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.