Connecting CPAP patients and their doctors through richer sleep data. Sensors embedded in the mask you already wear record SpO2, pulse rate, and position during the night — for you and your provider to review.
10 million Americans use CPAP, yet their machines only track airflow and leak. Orma is building a mask that also records what your body does during sleep — nightly data patients can see and doctors can review.
The mask is in development toward FDA 510(k) clearance. The goal: better-informed care between visits, with nothing extra to wear.
In a 300-patient study, built-in PAP software wrongly classified 28% of patients as "well controlled" when full sleep testing showed they still had significant residual apnea. Fanfulla et al., 2021
PAP-derived AHI is not equivalent to clinically validated metrics. Patients reporting fatigue and poor sleep are often overlooked when machine data shows a low number, missing residual disease. Sleep Review, 2026
CPAP preferentially improves cardiovascular outcomes in high-risk patients, identified by hypoxic burden and heart-rate response, signals current machines do not capture. Eur Heart J, 2026
Analysis of the 2,687-patient SAVE trial revealed significant heterogeneity in how patients respond to CPAP, underscoring the need for individualized, continuously monitored care. Communications Medicine, 2026
Embedded Biosensors — PPG, accelerometer, and temperature sensors in the mask frame. SpO2, HR, HRV, body position, and skin temperature collected passively every night.
Signal Analysis — Algorithms turn each night's raw signals into clear, reviewable summaries. Deeper sleep-analysis models are in research, being validated the proper way.
Doctor-Patient Data Bridge — A clinician dashboard delivers longitudinal data in standardized formats, keeping doctors in the loop between visits.
Companion App — Translates each night's recorded data into plain language, so you can see your own patterns and share them with your care team.
The building blocks behind the Smart CPAP Mask platform.
Medical-grade PPG sensor, multi-axis accelerometer, and temperature sensor. Low-power BLE 5.0 streams data to a companion app. Designed for nasal pillow and cradle mask form factors.
Deep-learning research models trained on PPG-derived signals — designed to be validated against polysomnography before any capability is claimed.
In development: tools that organize each night's recorded data into clear summaries for clinicians, and plain-language recaps for patients.
End-to-end encryption, HIPAA-compliant cloud, role-based access, audit logging, and BAA-ready architecture from day one.
Three signals, one mask — SpO2, heart rate, and body position, in the companion app.
Every minute of the night, recorded by the mask you already wear — yours to review, and to share with your provider.
Pulse rate from the same sensor, all night. Simulated sample — the mask is in development.
Time in bed and body position are recorded tonight. Sleep staging and arousal detection are in development.
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Not part of this preview. Tap the home icon to go back to the night.
This is a working preview of the design, not a released product. The mask is in development toward FDA 510(k) clearance, and every number here is simulated.
Wake up to the story of your night — every heartbeat of it, written while you slept.
Simulated signals — illustrative sample, not patient data.
Everything a consumer tracker does — built into the mask you already wear.
| Capability |  ORMA SMART MASK |
 STANDARD CPAP |
 CONSUMER TRACKERS |
|---|---|---|---|
| Sleep Stage Tracking | ✓ In development | ✗ | ~ Limited |
| Arousal Detection | ✓ In development | ✗ | ✗ |
| SpO2 Recording | ✓ Every night | ✗ | ~ Spot / wrist |
| HR / HRV Tracking | ✓ PPG-based | ✗ | ✓ |
| FDA Clearance Path | ✓ 510(k) pathway (in process) | ✓ Mask only | ~ Wellness |
| Nothing Extra to Wear | ✓ Built-in | ✓ | ✗ Ring/band |
| Physician Data Access | ✓ Clinician dashboard | ~ Compliance | ✗ Consumer |
| Insurance Reimbursement | Under evaluation | ✓ DME | ✗ OOP |
Three years on CPAP and I couldn’t tell you one thing about my nights. The machine knew. I didn’t.
I still woke at 3 a.m. to check that he was breathing. I needed to see the night somewhere.
Between visits I get usage hours and a leak number. My patients live a whole night I never see.
I quit my mask twice. Not because it wasn’t working — because nothing showed me it was.
SpO2, pulse rate, and position during the night.
You and your provider — recorded so you both have more to look at between visits.
End-to-end encryption, a HIPAA-compliant cloud, role-based access, and audit logging — BAA-ready architecture from day one.
The Orma smart mask is in development and pending FDA review — we're targeting U.S. availability in early-to-mid 2027, subject to FDA 510(k) clearance. Save your spot and we'll email progress updates, then let you know when ordering opens.
Joining is free and isn't a pre-order — no payment, no commitment. The Orma mask can be offered for sale only after FDA clearance. Unsubscribe anytime. Prefer email? hello@ormasleep.com