Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- OSA
- Sponsor
- Biocubica srl
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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)
Time Frame: 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
Time Frame: 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 Outcomes
- Patient satisfaction(Day 1)