OSASOUNDINCT06320795
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
A study testing SOUNDI in people with OSA, run by Biocubica srl at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- OSA
- What is being tested?
- SOUNDI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Pacemaker wearer
- Allergies to any material of the device
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca
Milan, 20149
About this study
Official title: 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.
- Conditions
- OSA
- Being tested
- SOUNDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOUNDIDevice
Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults.
| Study group | Role | What they receive |
|---|---|---|
| Soundi | Experimental | Soundi device compared to overnight polysomnography Receives: Device: SOUNDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Months
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction were determined by interview.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start22 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocubica srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carolina Lombardi, Prof., Principal investigator, Istituo Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320795
- Sponsor's protocol ID
- IT-MF-000031905
- Acronym
- SOUNDI
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi
- ClinicalTrials.gov ID
- NCT06320795
- Acronym / sponsor ID
- SOUNDI / IT-MF-000031905
- Conditions
- OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Biocubica srlIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soundi | Experimental | Device: SOUNDISoundi device compared to overnight polysomnography |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Pacemaker wearer
- Allergies to any material of the device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOUNDIContinuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults. | Device | Soundi |
Primary outcome
To evaluate the accuracy of the clinical diagnosis of OSA
Time frame: 6 Months
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.
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)
Time frame: 6 Months
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.
1 secondary outcome
Patient satisfaction
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for OSA
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Lombardi, Prof. principal investigator
Istituo Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOUNDI in people with OSA, run by Biocubica srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the accuracy of the clinical diagnosis of OSA (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.