OSA
Conditions
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.
Interventions
DEVICESOUNDI
Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults.
Sponsors
Biocubica srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | Day 1 | Patient satisfaction were determined by interview. |
Countries
Italy
Outcome results
None listed