- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04873193
Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children
Safety and Feasibility of Utilizing a Novel Wearable Device (Leo) for Assessing Respiratory Function in Children With Respiratory Condition - a Pilot Early Phase Clinical Study
This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma).
There is no product currently on the market that is comparable to this novel Leo device
The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma.
Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.
There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80045
- Children's Colorado Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Children aged ≥3 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
- Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
- Children who are able to follow instructions and complete oscillometry and tidal breathing tasks
Exclusion Criteria:
- - Children <3 and >18 years of age
- Adults (age ≥ 18 years)
- Children with complex medical conditions which may hinder their ability to complete protocol assessments
- Children who do not have a legal guardian to sign informed consent form
- 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
- Child is determined not eligible by the assessment of the PI
- Fever within the 4 weeks prior to enrollment
- 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
- Children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Faisabilité de l'appareil
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Oscillometry + Pneumotach Procedure with Leo Device measurements
All patients will undergo oscillometry procedure, followed by pneumotach procedure to measure tidal volume in different sitting positions. The Leo device will be worn throughout both procedures to measure the chest electrical impedance and compare against pneumotach measurements. Oscillometry and pneumotach are part of standard of care. |
Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Slow vital capacity from Leo device
Délai: Baseline
|
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device.
The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Slow vital capacity from PNT device
Délai: Baseline
|
Agreement and correlation in the lung function parameters derived using the respiratory impedance signals recorded from Leo device, compared to the pneumotachograph (PNT) device.
The PNT device readings will be considered the standard of care, and compared against the Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Tidal breathing from Leo device
Délai: Baseline
|
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device.
The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
|
Tidal breathing from PNT device
Délai: Baseline
|
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device.
The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate for device feasibility.
This will be done before and after administration of bronchodilator.
|
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Usability
Délai: Baseline
|
Clinician, patient and caregiver usability feedback on the use of the Leo device through an IRB approved participant questionnaire.
|
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Andrew Liu, Children's Hospital Colorado
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- OTH-21-02-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Type d'informations de prise en charge du partage d'IPD
- Protocole d'étude
- Plan d'analyse statistique (PAS)
- Formulaire de consentement éclairé (ICF)
- Rapport d'étude clinique (CSR)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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