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

Launched by BELUN TECHNOLOGY COMPANY LIMITED · Oct 9, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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.