Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device

OSA Clinical Trial

— SOUNDI  

Official title:

Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320795
• Other study ID #: IT-MF-000031905
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Biocubica srl
• Contact: Caterina Salito, PhD
• Phone: (39) 02 84072109
• Email: caterina.salito[@]biocubica.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 31, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• OSA

Intervention

Device:
• SOUNDI
Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults.

Locations

Country	Name	City	State
Italy	Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Biocubica srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Patient satisfaction	Patient satisfaction were determined by interview.	1 Day