Non-invasive detection of right-to-left shunts with the SONAS headband
Official title: Novel Approach For The Non-Invasive Detection of Pulmonary Right-to-Left Shunts
Run by St. Antonius Hospital · NCT07414446 · Data updated 2026-11-12
This will test whether the SONAS headband can find right-to-left shunts in adults with hereditary hemorrhagic telangiectasia (HHT) who are already having a bubble heart ultrasound (TTCE).
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | St. Antonius Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Nieuwegein, Utrecht) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | April 1, 2026 |
| Study ends | April 1, 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07414446 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with suspected or confirmed HHT or patients with cryptogenic stroke who are already scheduled for a contrast TTCE are the ideal candidates.
✕Probably not a fit
People who are pregnant or breastfeeding, have skull fractures, metal skull implants, open wounds or incompatible head/ear anatomy that prevents proper headset placement, or allergies to parabens in the device gel will not be eligible and may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults already scheduled for a contrast transthoracic bubble echocardiogram (TTCE) will wear a soft SONAS headband with ultrasound sensors while the standard bubble injection is performed. SONAS continuously records brain signals at rest and during a Valsalva maneuver while TTCE images the heart, allowing direct comparison of the two methods. The goal is to measure how often SONAS detects the same shunts as TTCE and whether its signals can help distinguish shunts originating in the heart from those in the lungs. All procedures are non-invasive and added to routine clinical care for a single visit.
Why it matters
Potential benefit: If successful, SONAS could offer a quicker, portable and easier way to screen for right-to-left shunts, helping identify patients who need further testing or treatment.
How similar studies have gone: Established approaches like transcranial Doppler and contrast echocardiography reliably detect right-to-left shunts, but the SONAS headband is a newer portable implementation with limited prior testing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older. * Suspected or confirmed hereditary hemorrhagic telangiectasia (HHT). * Incidentally: Patients who have experienced cryptogenic stroke Exclusion Criteria: * Pregnancy or breastfeeding. * Known or suspected fracture(s) of the temporal / parietal skull bones, or with open skin injuries in the anatomical area of the temporal / parietal lobes. * Patients with known metal skull implants in the anatomical area of the temporal / parietal bones, or with anatomical formation of the head or ear tha may interfere with proper headset placement. * Patients with known allergies or reactions to parabens, which are present in the gel pad material of the applied part.
Where it's running
-
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands Recruiting
Study contacts
- Principal investigator: Martijn C. Post, Professor — St. Antonius Hospital
- Study coordinator: Pier HJ van Veen, Medical Doctor
- Email: ja.van.veen@antoniusziekenhuis.nl
- Phone: 0883205336
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.