Recruiting

Observational Study

Sponsor:

ResMed

Code:

NCT05308277

Conditions

Asthma in Children

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Leo device monitoring

Study Details

Brief summary:

This is a prospective, observational study to investigate the agreement of the Leo device signal derivation with gold standard asthmatic testing in recently exacerbated asthmatic children.

This study is designed for engineering validation of a wireless, wearable device (Leo) for assessing clinical control of children recovering from acute respiratory event such as asthma attack. The Leo device will monitor chest impedance, ECG and body position to calculate parameters such as respiration rate, heart rate, lung volume, tidal breathing flow and volume curves, and body position. These parameters will then be used to train and algorithm to assess clinical control of asthma.

Conditions

Asthma in Children

Study ID

NCT05308277

Start date

Apr 27, 2022

Status verified date

Sep, 2022

Completion date

Apr, 2023

Anticipated

Primary completion date

Apr, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children aged ≥2 years old and <18 years old at time of consent
  • Children with a legal guardian able to sign consent for study participation
  • Children and caregivers able to read and understand English or Spanish
  • Children who are currently hospitalized with acute exacerbation of asthma
  • Child's caregiver is able to communicate using SMS
  • Child has an asthma inhaler

Exclusion Criteria:

  • Children with complex medical conditions which may hinder their ability to complete protocol assessments
  • Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
  • Children with any implanted medical devices, E.g. cardiac pacemaker
  • Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Single Arm - Leo Device Monitoring

Child's respiratory impedance will be continuously recorded using the Leo device during hospital/ED stay after consent and enrollment, and then during 7 days at home after discharge. The Leo device provides no intervention, and will only monitoring chest impedance for the worn period. Oscillometry and spirometry testing and flow volume assessment using PNT will be performed during study visits with Leo device attached.

Interventions

Leo device monitoring

After consent and enrollment, the child's respiratory impedance will be continuously recorded using the Leo device throughout the day and night during the entire hospital stay or ED visit. The device may be taken off for up to 1 hour per day (i.e., break during bath / shower time). The device will be applied to the skin overlying the mid-sternum area on the chest wall after cleaning of the skin with an alcohol swab after consent has been obtained. The device will be changed every 72 hours or earlier, by the participant's guardian, depending on signs of defect in the signal quality or battery exhaustion, based on daily check of the signal by the research team. Remote monitoring of the child's chest impedance will continue using the Leo device after discharge from hospital/ED for 7 days.

Primary outcome measure

  • Airway resistance through oscillometry test [ Time Frame: Baseline visit and 7 days post hospital/ED discharge ]
  • Asthma Flare-up diary [ Time Frame: Follow-up for 7 days post hospital/ED discharge ]
  • CASI questionnaire [ Time Frame: Baseline visit and 7 days post hospital/ED discharge ]

Central Contacts and Locations

Central contacts

Faizan Javed, PhD

+61 413624856faizan.javed@resmed.com.au

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Juana Cerna, MS

720-777-8384

More Information

Sponsor

ResMed

Last update posted

Sep 26, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ResMed on 2022-09-26.