(MICA) Mechanistic Study of Inspiratory Training in Childhood Asthma

(MICA) Mechanistic Study of Inspiratory Training in Childhood Asthma

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Purpose of this Study

We are doing this study to find out if breathing exercises can improve lung function for kids who have asthma.

Who Can Participate?

Eligibility

Children ages 6-17 who:
  • Have asthma that requires 2 or more medications to control symptoms
  • Are seeing a doctor at Duke about their asthma
  • Have obesity or are a normal weight
For more information about this study, contact the study team at taheerah.watson@duke.edu.

Age Range

6-17

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If your child is eligible and you allow them to join the study, they will:
  • Come in for a visit to make sure they are eligible to join (V1). They will then complete a screening period which lasts about 2-3 weeks and includes using a PrO2 breathing device and wearing an activity watch and patch.
  • Come in for a 2nd visit (V2) and get a random assignment (fair, equal chance) to 1 of 3 levels of resistance breathing exercises (high, low, or no resistance). For about 8 weeks, your child will perform breathing exercises with the PrO2 device 3 times per week at the assigned level of resistance and continue to wear the activity watch and patch.
  • Have a phone call with a study team member to see how they are doing (V3) and come in for the last visit at 8 weeks (V4).
  • Have phone calls with the team at 2 and 6 weeks of doig the breathing exercies.
At all study visits, your child will complete questionnaires, perform breathing exercises, and physical activity tests.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Principal Investigator

Jason
Lang

Protocol Number

PRO00112858

NCT ID

NCT05945355

Phase

II

Enrollment Status

Open to Enrollment