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

NCT06320795 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-07

No results posted yet for this study

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.

Conditions

  • OSA

Interventions

DEVICE

SOUNDI

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

Sponsors & Collaborators

  • Biocubica srl

    lead INDUSTRY

Principal Investigators

  • Carolina Lombardi, Prof. · Istituo Auxologico Italiano

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06320795 on ClinicalTrials.gov