Trials / Completed
CompletedNCT06320795
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Biocubica srl · Industry
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SOUNDI | Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults. |
Timeline
- Start date
- 2023-11-22
- Primary completion
- 2024-04-30
- Completion
- 2024-04-30
- First posted
- 2024-03-20
- Last updated
- 2024-08-07
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06320795. Inclusion in this directory is not an endorsement.