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:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT02206750
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women between 18 and 33 years of age.
1. 4-point Perceived Stress Symptom score \<2 or \>6
2. Physical conditioning allowing intermittent, moderate exercise for two hours.
3. Ability to complete the exposure exercise regimen without reaching 80% of predicted maximal heart rate.
Predicted maximal heart rate will be calculated using the equation (described by Tanaka et al. \[2001\] J. Am. Coll. Cardiol.): \[208bpm-((0.7) x (age in years))\]
4. Normal baseline 12-lead resting EKG, or if the automated reading is not normal the EKG must be approved by a study cardiologist.
5. Normal lung function Forced vital capacity (FVC) ≥ 80% of that predicted for gender, ethnicity, age and height (according to NHANESIII guidelines).
Forced expiratory volume in one second (FEV1) ≥ 80%of that predicted for gender, ethnicity, age and height.
FEV1/FVC ratio ≥ 80% of predicted values.
6. Oxygen saturation ≥ 96% on room air.
Exclusion Criteria:
* . Individuals with a history of acute or chronic cardiovascular disease, chronic respiratory disease, diabetes, rheumatologic diseases, or immunodeficiency state.
2\. Individuals with a Framingham risk score (Hard Coronary Heart Disease; HCHD; 10-year risk) ≥10.
3\. Individuals with asthma or a history of asthma. 4. Individuals who are allergic to chemical vapors or gases. 5. Females who are pregnant, attempting to become pregnant, or breastfeeding. 6. Individuals that are unwilling or unable to stop taking vitamin C or E, or medications that may impact the results of ozone challenge such at least two weeks prior to the study and for the duration of the study. Medications not specifically mentioned here may be reviewed by the investigators prior to an individual's inclusion in the study.
7\. Individuals who have smoked tobacco during the last five years or those with a history of \>5 pack years.
8\. Individuals living with a smoker who smokes inside the house. 9. Individuals with a body mass index (BMI) \>35 or \<18. Body mass index is calculated by dividing the weight in kilograms by the square of the height in meters.
10\. Individuals with occupational exposures to high levels of vapors, dust, gases, or fumes on an on-going basis.
11\. Individuals with uncontrolled hypertension (≥150 systolic or ≥90 diastolic).
12\. Individuals that do not understand or speak English. 13. Individuals that are unable to perform the exercise required for the study. 14. Individuals that are taking beta blocker medications. 15. Individuals with a history of skin allergies to adhesives used in securing EKG electrodes.
16\. Individuals with unspecified diseases, conditions, or medications that might influence the responses to the exposures, as judged by the medical staff.
17\. Individuals that are unwilling or unable to stop taking over-the-counter pain medications such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), or other non-steroidal anti-inflammatory ("NSAID") medications for 48 hours prior to the exposures and post-exposure visits.
18\. Individuals that are taking systemic steroids or beta-blocker medications. 19. Individuals with a hemoglobin A1c (HbA1c) level \> 6.4%.
Temporary Exclusion Criteria
1. Individuals with active seasonal allergies during the time of participation in the study.
2. Individuals suffering from acute respiratory illness within four weeks prior to any of the study exposure series.
3. Individuals that have been exposed to smoke and fumes within 24 hours of any study visit.
4. Individuals that have consumed alcohol within 24 hours of any study visit.
5. Individuals that have engaged in strenuous exercise within 24 hours of any study visit.
6. Individuals that have been exposed to ozone-based home air purifiers within 24 hours of any study visit.
7. Individuals that have been exposed to unvented household combustion sources (gas stoves, lit fireplaces, oil/kerosene heaters) within 48 hours of any study visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
33 Years
Study:
NCT02206750
Study Brief:
Protocol Section:
NCT02206750