Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
- Conditions
- OSA
- Interventions
- Device: SOUNDI
- Registration Number
- NCT06320795
- Lead Sponsor
- Biocubica srl
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Pregnancy
- Pacemaker wearer
- Allergies to any material of the device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Soundi SOUNDI Soundi device compared to overnight polysomnography
- Primary Outcome Measures
Name Time Method To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with SOUNDI and the home sleep study with polysomnography (PSG) 6 Months To evaluate the agreement between the AHI from the home sleep study with SOUNDI and the home sleep study with PSG in patients being referred to sleep clinics with suggestive OSA symptoms.
To evaluate the accuracy of the clinical diagnosis of OSA 6 Months To evaluate the accuracy of the clinical diagnosis of OSA assisted by the home sleep study with SOUNDI against the clinical diagnosis assisted by the PSG as the reference standard.
- Secondary Outcome Measures
Name Time Method Patient satisfaction Day 1 Patient satisfaction were determined by interview.
Trial Locations
- Locations (1)
Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca
🇮🇹Milan, Italy