Last reviewed · How we verify
NCT07086742: SMV1: PPG
Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
NA trial testing Smart Mask V1 System in Sleep-disordered Breathing (SDB) in 36 participants. Currently enrolling.
15 December 2025
Quick facts
| Lead sponsor | Pathway Medtech, LLC. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 1 September 2025 |
| Primary completion | 15 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Smart Mask V1 System
Conditions studied
- Sleep-disordered Breathing (SDB) — all drugs for Sleep-disordered Breathing (SDB) →
- Sleep Apnea — all drugs for Sleep Apnea →
- Sleep Quality — all drugs for Sleep Quality →
Sponsor
Pathway Medtech, LLC.
Who can join
Adults 18 to 65, any sex, with Sleep-disordered Breathing (SDB) or Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18 to 65. More specifically, the study is directed at answering the following questions: * Can the Smart Mask accurately measure SpO2 levels compared to established reference devices (reference oximeters, blood gas) throughout the range of SpO2 \~ 70 - 100%? * Can the Smart Mask accurately measure PR during the same conditions? * Does skin pigmentation impact the accuracy of Smart Mask's measurements of SpO2 and PR. The following reference devices will be used in the study: * An FDA-cleared fingertip pulse oximeter (Nellcor Portable SpO2 Patient Monitoring System, PM10N) * A laboratory-grade CO-oximeter (Radiometer ABL90 FLEX) that analyzes oxygen saturation from blood samples. Study participants will: * Wear the Smart Mask on their face and a fingertip pulse oximeter while lying down * Breathe air with gradually reduced oxygen levels inside a specialized hypoxia room while being closely. * In a second phase of the study, have a catheter inserted into a wrist artery for blood sampling to directly measure oxygen levels with the CO-oximeter.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07086742
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sleep-disordered Breathing (SDB)
Currently open trials in the same condition.
- NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
- NCT07332780 — Effect of Adenotonsillectomy on Spinal Curve Magnitude in Children With Sleep-Disordered Breathing · 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)
- Trial protocol + status: ClinicalTrials.gov NCT07086742 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pathway Medtech, LLC.
- Last refreshed: 17 August 2025
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/NCT07086742.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing