Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT04702620
Eligibility Criteria:
Inclusion Criteria:
* For all children, 2 to 36-months-olds, term birth (\> 37 ga), birth weight \> 3 Percentile, no hospitalisation for newborn respiratory distress, family aware of the use of the medical device, family of legal guardian consent to the study. According to the group, group 1: no history of chronic rhinitis, bronchiolitis or asthma, no respiratory allergy, no current acute disease, group 2: no history of chronic rhinitis, bronchiolitis or asthma, no respiratory allergy, no history of chronic rhinitis, bronchiolitis or asthma, no respiratory allergy, presence of current non-wheezing respiratory disease or fever, group 3: presence of current wheezing episode
Exclusion Criteria:
* Tonsil hypertrophy with respiratory impact
* Clinical sleep apnea syndrome (snoring or apnea noted or breathing obstructed during sleep)
* Use of rapid onset bronchodilator for less than 8 hours (except for asthmatic infants included in an exacerbation)
* Anti-asthma treatment in progress (except for asthmatic infants included during an exacerbation)
* Known chronic cardio-respiratory or other pathology that may have a respiratory impact.
* Skin pathology preventing DM placement
* Patients with a pacemaker, continuous glucose monitor, or any other connected or implanted electronic or other medical device (e.g. ECG)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
36 Months
Study:
NCT04702620
Study Brief:
Protocol Section:
NCT04702620