CE
2717
CE-marked
Class IIa
PSG
Validated against polysomnography
QMS
ISO 13485 quality system
HDS
Certified health data hosting
with your smartphone
Apneal is a CE-marked Class IIa medical device that uses a smartphone at home to support sleep apnea screening and aid diagnosis
Performance validated against polysomnography, the gold standard
Sensitivity
AHI ≥15 events/h vs PSG.
Specificity
AHI ≥15 events/h vs PSG.
ICC, AHI vs PSG
Mean bias 0.03 events/h
Patients analysed
491 enrolled · 9 centres · 3 countries
Severe cases missed
No PSG-severe patient was classified as normal in EASY study
Single-Centre validation
46 patients at Hôpital Bichat (AP-HP), simultaneous PSG. 90% correlation with polysomnography. Published in Sleep & Breathing, 2025.Multicentre, 3 countries, vs PSG
491 patients enrolled, 432 analysed in 9 sleep centres in France, Spain and Germany. Independent, Inserm-sponsored. Supports the CE Class IIa marking.At home, 10 centres in France
374 patients analysed at home (NCT06578390). Interim analysis of 85 patients: 91% correlation, confirming laboratory performance in real-life conditions. Presented at SFRMS 2025.
Certified Class IIa medical device for sleep apnea diagnostic support — across Europe
With Class IIa CE marking, the Apneal report is not only a screening alert: it can be used by a healthcare professional as part of their clinical evaluation. The CE marking applies to the whole European market; integration into each diagnostic pathway depends on national health-system rules, and a confirmatory exam may be required depending on the clinical situation.
Apneal among the AI devices reviewed by BSI, our notified body
Sleep-Related Breathing Disorders in Numbers
People affected worldwide
Sleep-related breathing disorders, including sleep apnea, affect over 900 million people globally — a major public health issue.
Cases remain undiagnosed
More than 80% of cases are never identified, leaving millions exposed to untreated cardiovascular and metabolic risk and persistent fatigue.
Higher risk of complications
Untreated sleep disorders increase the risk of life-threatening conditions, such as cardiovascular disease, by up to five times.
Apneal's solution
The same cardiorespiratory signals as a sleep test — without the hardware or its constraints
Polysomnography and home polygraphy require dedicated equipment, delivery logistics and a healthcare professional to set up — barriers for patients and health systems alike.
Apneal captures the same physiological signals through the sensors already inside the patient’s smartphone, and analyses them with AI to produce a clinical report that physicians can use in their diagnostic evaluation.
No device to ship, retrieve, clean or maintain. No accessory. No electronic waste. The test can start the very night of the consultation.
Simple and Secure Setup
The smartphone is placed on the chest, over pyjamas, held by adhesive and cohesive bands available at any pharmacy — with airplane mode activated. The app guides each step, and the night is spent naturally, in one's own bed, in any position.
Overnight Cardiorespiratory Recording
The sensors already inside the phone record breathing movements, breathing sounds and snoring, and heart rate — the same cardiorespiratory signals a sleep test measures, captured differently. Over 95% of smartphones are compatible; nothing else is needed.
A Clinical Report the Next Morning
Apneal's AI counts the breathing events of the night — the apnea–hypopnea index — estimates sleep time and tells central events from obstructive ones. A clear night summary is available in the app, and a full report — in the same format as a standard sleep test — is shared with the prescribing physician, who makes the diagnosis.
Streamlined Care
for Sleep apnea
Apneal enters the care pathway as diagnostic support: fewer barriers for patients, faster orientation for clinicians, and sleep-centre resources kept for the cases that need them. The medical decision stays with the physician — every time.
For the patient
A guided, wire-free test in their own bed, starting the night of the consultation, with a personalised night summary the next morning. Fewer hospital nights, faster access to care.
For sleep specialists
A polygraphy-style report — AHI, sleep time, central vs obstructive events — to prioritise referrals, replace home polygraphy for standard patients and keep polysomnography for complex cases. The diagnosis remains yours.
For frontline healthcare professionals
A reliable first-line test for sleep apnea, with integrated clinical questionnaires, to quickly identify the patients who need specialist referral — without any equipment to stock.
For home care providers
Multi-night recording without hardware logistics: capture night-to-night variability, support treatment titration and long-term follow-up, and keep patients engaged.
Diagnostic support within your patients’ reach
Whether you are a sleep specialist, a frontline clinician, a home care provider or a health-system decision-maker, our team is ready to help you bring Apneal into your care pathway.