Status:
RECRUITING
Finding Correlations Between Asthma Exacerbation, Physiological Measurements and Environmental Factors
Lead Sponsor:
North Carolina State University
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Conditions:
Asthma
Eligibility:
All Genders
14-18 years
Brief Summary
To identify asthma-related physiological changes observed by wearable devices in real-world conditions by monitor multiple sensing modalities (e.g., heart rate (HR), heart rate variability (HRV), acti...
Detailed Description
The study aims to identify asthma-related physiological changes observed by wearable devices in real-world conditions. The investigators aim to monitor multiple sensing modalities (e.g., heart rate (H...
Eligibility Criteria
Inclusion
- Adolescents (14-18 years old) with asthma will be included.
- Participants will have to be diagnosed with persistent asthma (as characterized in their UNC health record) that is poorly controlled since this is the focus of the study. They will be identified as eligible for inclusion by the UNC Coordinator partner. However, they should not have any other lung disease other than asthma. They should not be taking any oral steroids every day to control their asthma. They should not need to use their asthma rescue medication multiple times a day to help with their asthma symptoms. They should not have experienced wheezing brought on when performing a lung function test.
- Participants should have Wireless Internet access at their homes
- Individuals with COVID-19 symptoms will be automatically excluded due to their clinical screening prior to their clinic visit. However, if a participant contracts COVID-19 during the study, they will be encouraged to continue participating since all interactions will be remote after the first clinical screening.
- Adolescents should be able to use a iOS device (provided by the researchers) and the devices (with assistance from parents when appropriate) for data collection efforts. They cannot participate in this study if they don't feel comfortable with operating the multiple devices including the iOS device. The iOS device can only be used for the purposes of this study. The iOS device will be restricted by enabling Parental Control Settings accessible only to the researchers.
- The participation of an adolescent may be terminated by the investigator if they do not follow the guidelines for the study, including using the devices as instructed or participating in the interviews and weekly surveys. Also, the monthly renewal for the participation of the study (up to 4 months) will be decided by the investigators on a month-by-month basis given that the participant also agrees to continue in the study.
- Individuals with physical challenges are allowed to be incidentally included as long as they satisfy all the previous criteria.
Exclusion
- none listed
Key Trial Info
Start Date :
September 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04845932
Start Date
September 1 2021
End Date
December 1 2024
Last Update
March 27 2024
Active Locations (1)
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1
UNC Children's Raleigh Clinic
Raleigh, North Carolina, United States, 27607