NCT06320795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

August 7, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 7, 2024

Last Update Submit

August 5, 2024

Conditions

OSA

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Patient satisfaction

    Day 1

Study Arms (1)

Soundi

EXPERIMENTAL

Soundi device compared to overnight polysomnography

Device: SOUNDI

Interventions

SOUNDIDEVICE

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

Soundi

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Pacemaker wearer
  • Allergies to any material of the device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca

Milan, 20149, Italy

Location

Study Officials

  • Carolina Lombardi, Prof.

    Istituo Auxologico Italiano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 20, 2024

Study Start

November 22, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

August 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)