Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device (SOUNDI)

Biocubica

Status: Completed

Conditions: OSA

Treatments: Device: SOUNDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT06320795

IT-MF-000031905

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Soundi

Experimental group

Description:

Soundi device compared to overnight polysomnography

Treatment:

Device: SOUNDI