Finding Correlations Between Asthma Exacerbation, Physiological Measurements and Environmental Factors

Status: Recruiting
Location: See location...
Study Type: Observational
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), activity level, spirometry, coughing sounds) in order to find reliable signatures of impending asthma exacerbation and systematically explore any challenges on the use of wearable technologies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
UNC Children's Raleigh Clinic
RECRUITING
Raleigh
Contact Information
Primary
Katie Mills
katherine.mills@unc.edu
919-966-2936
Backup
Edgar Lobaton
edgar.lobaton@ncsu.edu
919-515-5151
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: North Carolina State University
Collaborators: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov