CLINICAL VALIDATION
Scientific Evidence Supporting SleepWise
SleepWise has undergone multiple independent clinical validations, demonstrating its reliability and accuracy in diagnosing sleep-disordered breathing compared with traditional in-laboratory polysomnography (PSG) and home sleep apnea testing (HSAT).
These studies confirm that a contactless, software-based approach can reach clinical-grade performance while improving patient comfort and compliance.
Laboratory Validation – In-Hospital Study
A first validation study was conducted at the Sleep Unit of Hospital Universitari Germans Trias i Pujol (Barcelona, Spain), comparing SleepWise with standard PSG recordings in patients with suspected obstructive sleep apnea (OSA).
Population: 50 adult patients
Design: Simultaneous recording with SleepWise and full PSG
Parameters compared: Apnea-Hypopnea Index (AHI), sleep stages, respiratory events
Results:
- Sensitivity: 100%
- Specificity: 83%
- Positive Predictive Value: 97%
- Negative Predictive Value: 100%
- Intraclass correlation coefficient: 0.866 (p < 0.001)
Conclusion: SleepWise achieved excellent agreement with standard PSG in classifying OSA severity (mild, moderate, severe). The study confirmed that contactless motion analysis can accurately reproduce respiratory traces and event detection comparable to gold-standard measurements.
Reference: Abad et al., Sleep, 2016; 39(8):1507–1515.
Home Validation – Outpatient Study
A second validation was carried out across multiple centers to evaluate SleepWise performance for home-based sleep studies. The system was compared with both PSG and HSAT in 38 outpatients monitored for OSA.
Results:
- Concordance with PSG: Lin’s correlation coefficient = 0.933 (κ = 0.930)
- Concordance with HSAT: Lin’s correlation coefficient = 0.917 (κ = 0.793)
- Night-to-night reproducibility: Lin’s correlation coefficient = 0.923 (κ = 0.837)
- Ease of use: 100% of patients rated the system as “easy” or “very easy” to operate
Conclusion: SleepWise proved to be a highly accurate, repeatable, and comfortable method for home-based, automatic respiratory event detection and OSA classification.
Reference: Muñoz-Ferrer et al., Archivos de Bronconeumología, 2020; DOI:10.1016/j.arbres.2019.11.027.
Ongoing Clinical Research
SleepWise Healthcare continues to expand its clinical validation program, including:
- Paediatric studies in collaboration with European university hospitals
- Multi-night reproducibility assessments in real-world home settings
- Validation of extended parameters, including contactless estimation of oxygen desaturation
- Regulatory clinical trials to support CE and FDA certification processes
All studies are conducted under Good Clinical Practice (GCP) and approved by institutional review boards.
Summary of Validation Outcomes
| Parameter | Result | Reference |
|---|---|---|
| Sensitivity | 100% | “Abad et al., 2016” |
| Specificity | 83% | “Abad et al., 2016” |
| AHI Correlation (PSG) | r = 0.93 | “Muñoz-Ferrer et al., 2020” |
| Night-to-Night Reproducibility | r = 0.92 | “Muñoz-Ferrer et al., 2020” |
| Ease of Use | 100% of participants | “Muñoz-Ferrer et al., 2020” |
Clinical Takeaway
SleepWise achieves diagnostic accuracy equivalent to standard polygraphy and polysomnography, with the added benefits of:
- Full comfort and adherence (no sensors, no wires)
- Scalability for repeated or long-term monitoring
- Consistency across clinical environments
- Accessibility for home and paediatric populations
This strong body of evidence supports SleepWise as a validated, safe, and physician-centric diagnostic tool, paving the way toward CE and FDA certification.