AsthmaSCH AsthmaNCT04845932
Finding Correlations Between Asthma Exacerbation, Physiological Measurements and Environmental Factors
An observational study of Asthma, run by North Carolina State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Asthma
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with asthma will be included
Who may be able to join
- 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.
Who cannot join
- none listed
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UNC Children's Raleigh Clinic
Raleigh, North Carolina, 27607
Katie Mills, 919-966-2936, katherine.mills@unc.edu
About this study
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.
Read the 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 (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-week,1-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.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the correlation between continuous physiological measurements, inhaler usage and lung function outcomes from spirometry
Physiological measurements obtained from wearable devices (including motion, heart rate and heart rate variability) and from acoustic sensors (including audio from cough) will be correlated with outcomes from the daily spirometry measurements and inhaler use. Hand-crafted and data-driven features will be extracted for physiological measurements. Standard statistical tests will be used to determine significant correlations.
Measured: Continuously from baseline and up to 4 months
Secondary outcomes (1)
Develop a predictive model for asthma exacerbation and drop in lung function based on physiological measurements and inhaler usage
Results from the primary outcome will be used to build a data-driven predictive model for the detection of asthma exacerbation (as reported by the participants in their weekly survey) and drop in lung function (as measured by the spirometer). Standard metrics capturing specificity and sensitivity of the model will be used for evaluation. These models will be continuously developed after the completion of data collection from the first cohort.
Measured: Continuously from baseline and up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Sep 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Edgar Lobaton, North Carolina State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845932
- Sponsor's protocol ID
- 16598
- Acronym
- SCH Asthma
- Status last verified
- Mar 2024
- First submitted
- 31 Mar 2021
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Correlations Between Asthma Exacerbation, Physiological Measurements and Environmental Factors
- ClinicalTrials.gov ID
- NCT04845932
- Acronym / sponsor ID
- SCH Asthma / 16598
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Apr 2021 (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.
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.
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 (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-week,1-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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with asthma will be included
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- none listed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify the correlation between continuous physiological measurements, inhaler usage and lung function outcomes from spirometry
Time frame: Continuously from baseline and up to 4 months
Physiological measurements obtained from wearable devices (including motion, heart rate and heart rate variability) and from acoustic sensors (including audio from cough) will be correlated with outcomes from the daily spirometry measurements and inhaler use. Hand-crafted and data-driven features will be extracted for physiological measurements. Standard statistical tests will be used to determine significant correlations.
1 secondary outcome
Develop a predictive model for asthma exacerbation and drop in lung function based on physiological measurements and inhaler usage
Time frame: Continuously from baseline and up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by North Carolina State University 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katie Mills (919-966-2936, katherine.mills@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the correlation between continuous physiological measurements, inhaler usage and lung function outcomes from spirometry (time frame: Continuously from baseline and up to 4 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 27 Mar 2024.