AsthmaAPAMNCT06321471
AeviceMD for Pediatric Asthma Management
A study testing AeviceMD in people with Asthma and Asthma in Children, run by Irina Dralyuk at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Asthma, Asthma in Children, Pediatric Asthma
- What is being tested?
- AeviceMD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Known allergy to silicone, gold, or zinc
- Abnormal skin conditions on chest
- Sleep apnea diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the 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.
- Being tested
- AeviceMD
- Keywords
- Wearable Medical Device
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeviceMDDevice
AeviceMD is a remote patient monitoring system consisting of a wearable stethoscope, silicone patches, a docking station, and a mobile application.
| Study group | Role | What they receive |
|---|---|---|
| AeviceMD | Other | This is a single site, single arm, open label medical device (AeviceMD) pilot where only intervention groups will be recruited. Receives: Device: AeviceMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The study primary objectives are met if enrolled patients achieve better manage of their asthma shown by a reduction in admission rate, improvement in patient satisfaction, and quality of life. For this purpose, the Pediatric Asthma Control and Communication Instrument (PACCI) system will be utilized. This is a 12-item questionnaire resulting in a sum score ranging from 0 (best asthma control) to 19 (worst asthma control). A decrease in the sum score indicates an improvement in asthma control.
Measured: 3 Months
Secondary outcomes (1)
To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations.
The study's secondary objectives are met if a remote physician was able to conduct auscultation of a patient's lungs and discern between normal and abnormal breath using AeviceMD during teleconsultations. For this purpose the PI will test the sound quality of the AeviceMD in direct comparison to a traditional stethoscope used at baseline and final in-person visits, as well as at the tele visit.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start5 Nov 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irina Dralyuk
- Sponsor type
- University, hospital or other
- Collaborators
- Aevice Health Pte. Ltd.
- Responsible party
- Sponsor-investigator, Irina Dralyuk, Cedars-Sinai Medical Center
- Investigators
- Irina Dralyuk, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321471
- Sponsor's protocol ID
- STUDY00002858
- Acronym
- APAM
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AeviceMD for Pediatric Asthma Management
- ClinicalTrials.gov ID
- NCT06321471
- Acronym / sponsor ID
- APAM / STUDY00002858
- Keywords
- Wearable Medical Device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Irina DralyukUniversity, hospital or other
- Collaborators
- Aevice Health Pte. Ltd.
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AeviceMD | Other | Device: AeviceMDThis is a single site, single arm, open label medical device (AeviceMD) pilot where only intervention groups will be recruited. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Known allergy to silicone, gold, or zinc
- Abnormal skin conditions on chest
- Sleep apnea diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AeviceMDAeviceMD is a remote patient monitoring system consisting of a wearable stethoscope, silicone patches, a docking station, and a mobile application. | Device | AeviceMD |
Primary outcome
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.
Time frame: 3 Months
The study primary objectives are met if enrolled patients achieve better manage of their asthma shown by a reduction in admission rate, improvement in patient satisfaction, and quality of life. For this purpose, the Pediatric Asthma Control and Communication Instrument (PACCI) system will be utilized. This is a 12-item questionnaire resulting in a sum score ranging from 0 (best asthma control) to 19 (worst asthma control). A decrease in the sum score indicates an improvement in asthma control.
1 secondary outcome
To determine if the AeviceMD is effective as a remote auscultation tool for the facilitation of teleconsultations.
Time frame: 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irina Dralyuk, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AeviceMD in people with Asthma and Asthma in Children, run by Irina Dralyuk at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.