NCT06320795 (SOUNDI) is a NA clinical trial of SOUNDI in OSA, sponsored by Biocubica srl.

Who is sponsoring NCT06320795?

NCT06320795 is sponsored by Biocubica srl.

What drugs are being tested in NCT06320795?

Interventions in NCT06320795: SOUNDI.

Is NCT06320795 still recruiting?

NCT06320795 is currently completed. Last updated 7 August 2024.

Last reviewed 2024-08-07 · How we verify

NCT06320795: SOUNDI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 7 August 2024

What this trial tests

NA trial testing SOUNDI in OSA in 50 participants. Completed in 30 April 2024.

Timeline

22 November 2023

Primary endpoint
30 April 2024

30 April 2024

Quick facts

Lead sponsor	Biocubica srl
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	22 November 2023
Primary completion	30 April 2024
Estimated completion	30 April 2024
Sites	1 location across Italy

Drugs / interventions tested

SOUNDI

Conditions studied

OSA — all drugs for OSA →

Sponsor

Biocubica srl

Who can join

Adults 20 to 70, any sex, with OSA. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Clinical validation of a multisensor wearable device (SOUNDI) for the diagnosis of obstructive sleep apnea (OSA).
Salito C, Bovio D, Lombardi C. · · 2026 · PMID 41559161 · DOI 10.1038/s41598-026-36290-y

Verify or expand the search:

Other recruiting trials for OSA

Currently open trials in the same condition.

NCT06910930 — Impact of Muscle Training Device on Non-Severe OSA · NA · recruiting
NCT07060079 — The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease · recruiting
NCT06110962 — Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor · recruiting
NCT06591169 — Lifestyle Changes in PCOS with OSA and NAFLD · NA · recruiting
NCT06091098 — Reversible Effect of Falling Ventilatory Drive in Drive-dependent OSA · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06320795 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biocubica srl
Last refreshed: 7 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06320795.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing