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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults.
Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca
Milan, Italy
To evaluate the accuracy of the clinical diagnosis of OSA
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.
Time frame: 6 Months
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)
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.
Time frame: 6 Months
Patient satisfaction
Patient satisfaction were determined by interview.
Time frame: Day 1
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