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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT05246358
Eligibility Criteria:
Inclusion Criteria:
* Subject must have the ability to understand and provide written informed consent
* Subject is adult over 18 years of age
* Subject must be willing and able to comply with study procedures and duration
* Subject is a non-smoker, or a smoker who has refrained from smoking for 1 day.
* Male or female of any race
Exclusion Criteria:
Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoo in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
* Subjects with known respiratory conditions such as:
* uncontrolled / severe asthma,
* flu,
* pneumonia / bronchitis,
* shortness of breath / respiratory distress,
* respiratory or lung surgery,
* emphysema, COPD, lung disease
* Subjects with self-reported heart or cardiovascular conditions such as:
* high blood pressure: systolic \>140 mmHg or diastolic \>90 mmHg
* have had cardiovascular surgery
* chest pain (angina)
* heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
* previous heart attack
* blocked artery
* unexplained shortness of breath
* congestive heart failure (CHF)
* history of stroke
* transient ischemic attack
* carotid artery disease
* myocardial ischemia
* myocardial infarction
* cardiomyopathy
* Self-reported health conditions as identified in the Health Assessment Form
* diabetes,
* uncontrolled thyroid disease, kidney disease / chronic renal impairment,
* history of seizures (except childhood febrile seizures),
* epilepsy,
* history of unexplained syncope,
* recent history of frequent migraine headaches,
* recent head injury within the last 2 months,
* Cancer / chemotherapy
* Other known health condition, should be considered upon disclosure in health assessment form
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
52 Years
Study:
NCT05246358
Study Brief:
Protocol Section:
NCT05246358