Recruiting

Observational Study

Sponsor:

North Carolina State University

Code:

NCT04845932

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Study Details

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), 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.

Conditions

Asthma

Study ID

NCT04845932

Start date

Sep 1, 2021

Status verified date

Mar, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • none listed

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

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 ]

Central Contacts and Locations

Central contacts

Katie Mills

919-966-2936katherine.mills@unc.edu

Edgar Lobaton

919-515-5151edgar.lobaton@ncsu.edu

Locations

UNC Children's Raleigh Clinic

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Katie Mills

919-966-2936katherine.mills@unc.edu

More Information

Sponsor

North Carolina State University

Last update posted

Mar 27, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina State University on 2024-03-27.