Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04845932
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2021-03-31
Brief Title:
Finding Correlations Between Asthma Exacerbation Physiological Measurements and Environmental Factors
Sponsor:
North Carolina State University
Organization:
North Carolina State University
Study Overview
Official Title:
Finding Correlations Between Asthma Exacerbation Physiological Measurements and Environmental Factors
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCH Asthma
Brief Summary:
To identify asthma-related physiological changes observed by wearable devices in real-world conditions by monitor multiple sensing modalities eg 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
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 eg 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 A variety of off-the-shelf devices as well as the prototype HET platform developed by the NCSU ASSIST center will be used for data collection
The investigators plan to engage adolescents ages 14-18 for a period of up to four months of monitoring They will be asked to wear the wrist monitoring device for at least 8 hours daily and chest monitoring devices for at least 12 hours a week to take daily measurements using a spirometer and answer weekly questionnaires online and virtual interviews at 1-week1-month and 3-months about their asthma control and experiences with the devices
Wearable devices are increasingly popular with young people and are capable of providing dynamically calculated up-to-the-minute measurements of a number of physiologic parameters including heart rate heart rate variability respiratory rate activity levels and cough The cough sounds the investigators hope to capture during a forced-cough recording and while sleeping can be used as biomarkers for early detection of exacerbation These changes could be used to predict an asthma exacerbation and provide the wearer with instant feedback allowing the user to intervene early and prevent progression to more severe symptoms Young adults are likely to adopt wearable technologies to facilitate chronic disease management making this an ideal age group to examine the utility of wearable devices to detect early physiologic predictors of an impending exacerbation
The investigators plan to engage adolescents ages 14-18 for a period of up to four months of monitoring They will be asked to wear the wrist monitoring device for at least 8 hours daily and chest monitoring devices for at least 12 hours a week to take daily measurements using a spirometer and answer weekly questionnaires online and virtual interviews at 1-week1-month and 3-months about their asthma control and experiences with the devices
Wearable devices are increasingly popular with young people and are capable of providing dynamically calculated up-to-the-minute measurements of a number of physiologic parameters including heart rate heart rate variability respiratory rate activity levels and cough The cough sounds the investigators hope to capture during a forced-cough recording and while sleeping can be used as biomarkers for early detection of exacerbation These changes could be used to predict an asthma exacerbation and provide the wearer with instant feedback allowing the user to intervene early and prevent progression to more severe symptoms Young adults are likely to adopt wearable technologies to facilitate chronic disease management making this an ideal age group to examine the utility of wearable devices to detect early physiologic predictors of an impending exacerbation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None