Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea

Inclusion criteria

• Subject must have the ability to understand and provide written informed consent.
• Subject is 18 to 90 years of age.
• Subject must be willing and able to comply with study procedures and duration.
• Male or female of any race.

Exclusion criteria

• Subject requires oxygen therapy or noninvasive ventilation.
• Subject has a current diagnosis of chronic obstructive pulmonary disorder (COPD), neuromuscular disease, periodic limb movement, or narcolepsy.
• 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. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
• Subject is on medication known to interfere with heart rate, such as beta blockers, digoxin, or calcium receptor agonists.
• Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported).
• Unwillingness or inability to remove colored nail polish from test digits.
• Other known health condition, which should be considered.