Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device

Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi

This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders.

Inclusion Criteria:

• Patients who are able to understand the nature of the study and to give free informed consent
• Must be over 20 and referred by medical staff for an overnight assessment for suspected sleep apnea

Exclusion Criteria:

• Pregnancy
• Pacemaker wearer
• Allergies to any material of the device