Study of portable human exhaled breath condensate sampler to more accurately diagnose asthma, in a non-invasive way

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"Help us test the feasibility of a new device to diagnose asthma"
Age: 12-18 years old
Gender:
Any
Healthy Volunteers: No
Keywords: asthma
Type: Other
Investigator:
Description
Asthma is the most common chronic childhood disease, and asthma attacks are the most common reason children miss school. More than 5 million children have asthma and the prevalence of asthma in some inner cities in the United States is greater than 20%. Missed asthma diagnosis in children and poorly controlled asthma have tremendous economic impacts for school systems and families of asthmatic children.

This research is investigating the feasibility of a portable human exhaled breath condensate sampler to more accurately diagnose asthma in a non-invasive manner.
This study requires

You will be part of a research study by collecting your breath samples.

  • A portable exhaled breath sampler will be provided and used to collect samples.
  • Someone will explain the research study to you including the nature and purpose of the study, the procedures to be followed, and any potential risks.
  • Participants will collect a breath sample two times per day roughly 12 hours apart (morning and night) for 2 weeks. Each sample will take approximately 10 minutes of breathing into the sampler.
  • Additionally, an instruction manual on how to use the device will be provided. Data of tests taken may be sent to you and the research team via email on a regular basis. This information will contain non-personal data such as test date, duration, ambient temperature and humidity. This data will be used to determine if the device is functioning properly for sampling.
  • You will be required to store your small vial breath samples in your personal freezer until the graduate research coordinator retrieves them.
  • You will be interacting with the research team at the Bioinstrumentation and BioMEMS Laboratory through home visits, once per week calls, and/or email.
  • You will be responsible for using this device at home. However, initial and final tests will be conducted at the UC Davis Bioinstrumentation and BioMEMS Laboratory.
Who can participate

Inclusion criteria:

  • The children in this study will be within the specified range of ≥12 and ≤ 18 years of age.
  • They will have doctor diagnosed asthma with NAEPP definition of persistent asthma, a history of asthma symptoms in the past 2 months, use of controller asthma medications including inhaled corticosteroids (≥88 mcg of fluticasone/day or equivalent), as well as the demonstrated ability to perform FVC lung function maneuvers upon training and a willingness to complete study questionnaires and diaries.

Exclusion criteria:

  • We will not include severe asthmatics with baseline FEV1 <50% predicted so that the repeated lung function maneuvers for sampling do not exacerbate their asthma symptoms.
Benefits and risks of participating
There are no direct benefits to you as a result of your participation. We also cannot promise any health benefits to others as a result of your participation in this research. However, your participation will help in advancing development of a portable breath sampling procedure that will enable a more accurate, quick, and non-invasive diagnosis of asthma.

This study is a minimal risk research study. The following describes possible risks:
- Discomfort from breathing into the sampler for a given duration.
- Cross contamination occurring if more than one person uses the same device. You will be provided rubbing alcohol (70% Isopropanol 30% water) to clean designated parts of the portable breath sampler. You will be instructed on how to appropriately use the rubbing alcohol for cleaning the designated parts.
- Complete privacy cannot be promised with the disclosure of your personal information, including research study and medical records to people who have a need to review this information.
- Electrical shock by tampering with the electronics of the device. The electronics will be well connected and sealed to prevent this risk.
Compensation
If you complete the study you will be compensated with $200.00. If you agree to participate in the study, sign the consent form, and attend the first appointment, but you do not complete the study, you will be compensated with $50.00. You may be asked for your social security number for payment purposes. It will not be used for any other purpose without your permission. The form of payment will include a check from the UC Davis Regents and you should expect to receive it approximately one month after completing the study.
Resources
Schedule
Study duration and period
Two weeks
Recruitment period
From Sept. 7, 2017
Location
UC Davis Bioinstrumentation and BioMEMS Laboratory
1 Shields Avenue
Davis, CA 95616
Contact
Alexander Schmidt

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