Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device (SOUNDI)

Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi

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 Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Device: SOUNDI

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20149
    • Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soundi; Soundi device compared to overnight polysomnography	Device: SOUNDI; Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction were determined by interview.	Day 1

Collaborators and Investigators

• Sponsor: Biocubica srl
• Investigators: Principal Investigator: Carolina Lombardi, Prof., Istituo Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IT-MF-000031905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No