Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

NARecruitingINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

October 30, 2027

Study Completion Date

October 30, 2027

Conditions
Asthma in ChildrenObesityPediatric ObesityPediatric Asthma
Interventions
DEVICE

Pro2 - Low Dose - 40% of participant's MIP

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Successful IMR repetitions will require that subjects achieve a pressure target that is 40% of their MIP (maximum inspiratory pressure).

DEVICE

Pro2 - High Dose - 75% of participant's MIP

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their MIP (maximum inspiratory pressure).

DEVICE

Pro2 - SHAM - 15% of participant's MIP

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Successful IMR repetitions will require that participants achieve a pressure target that is 15% of their MIP (maximum inspiratory pressure).

Trial Locations (2)

27703

RECRUITING

Duke Health Center Creekstone, Durham

27704

RECRUITING

Duke Healthy Lifestyles Clinic, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

lead

Duke University

OTHER

NCT05945355 - Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA) | Biotech Hunter | Biotech Hunter