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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soundi | Experimental | Soundi device compared to overnight polysomnography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOUNDI | Device | Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction were determined by interview. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolina Lombardi, Prof. | Istituo Auxologico Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca | Milan | 20149 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2023 | Mar 13, 2024 | Prot_000.pdf |
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